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Purpose: The therapeutic efficacy of metastatic renal cell carcinoma (mRCC) has been significantly enhanced with the advent of immune checkpoint inhibitors (ICIs). However, there are limited data on the efficacy of Tislelizumab in patients with mRCC. This study aimed to assess the effectiveness and safety of Tislelizumab plus tyrosine kinase inhibitor (TKI) for patients with mRCC. Methods: Demographic and clinicopathological data of mRCC patients treated with first-line TKI monotherapy or Tislelizumab plus TKI therapy between March 2019 to February 2023 were collected. Outcome measures included the objective response rate (ORR), median progression-free survival (mPFS). Patient baseline characteristics and adverse events (AEs) were documented. Results: Totally 136 patients were included in the analysis, with a median age of 57 years. Of the patients, 72.1% were male, 78.8% with intermediate/poor-risk disease. For the overall population, the combination group (n = 61) exhibited a longer PFS compared to the TKI monotherapy group (n = 75) (mPFS (95% CI): 15.9 (10.9–20.9) vs. 6.2 (5.4–6.9) months, P < 0.001) and improved ORR (44.3% vs. 18.7%, P = 0.001). In the non-clear cell RCC (nccRCC) subgroup (n = 39), the combination group (n = 20) showed improved PFS (mPFS (95% CI): 11.9 (0.6–23.3) vs. 4.6 (3.4–5.9) months, P < 0.001) and ORR (40.0% vs. 10.5%, P = 0.006) compared to the TKI monotherapy group (n = 19). The incidence of grade three or higher treatment-related AEs are comparable between the groups (47.54% vs. 40.00%). Conclusion: Our data demonstrated the promising efficacy and safety profile of Tislelizumab plus TKI as first-line treatment for both ccRCC and nccRCC. [ABSTRACT FROM AUTHOR]

Monoclonal antibodies (mAbs) have completely changed the face of oncology over the last 50 years, and they have contributed to a major breakthrough in terms of cancer therapy. Esophageal and gastric cancers, the eighth and fifth most commonly diagnosed types of cancer worldwide, respectively, have lately, been managed more effectively, with the introduction of new therapeutic treatment strategies, especially mAbs. Combination treatments and new molecules have changed the face of the disease, while more therapies are getting approved on a daily basis. This review aims to analyse the major up-to-date clinical trials using mAbs and immunotherapy for the treatment of advanced gastro-esophageal cancers. [ABSTRACT FROM AUTHOR]

Background: Tislelizumab has emerged as a promising therapy for unresectable hepatocellular carcinoma (uHCC), although its economic viability across different healthcare systems remains uncertain. Aim: This study compared the cost-effectiveness of tislelizumab versus sorafenib as a first-line treatment for uHCC from the perspectives of the healthcare systems of China, the United States and Europe. Method: A partitioned survival model was developed using data from the RATIONALE-301 trial. Costs and utilities were sourced from local healthcare charges, publicly available databases, and published literature. Total costs, quality-adjusted life years, and incremental cost-effectiveness ratios (ICERs) were assessed. Price simulations were conducted to identify cost-effective pricing within established willingness-to-pay (WTP) thresholds. Sensitivity and scenario analyses were performed to test the robustness of the model. Results: Tislelizumab (priced at $1587.45/100 mg) was cost-effective in the US at a WTP threshold of $150,000, with an ICER of $108,812.52. In Europe, tislelizumab was cost-effective at a WTP threshold of $100,000, with an ICER of $94,880.40. For $186.18/100 mg in China, tislelizumab was cost-effective with an ICER of $14,206.80. Price simulation analyses showed that in the US, tislelizumab was favored when priced below $1438.30/100 mg at a $100,000 WTP threshold and below $2284.56/100 mg at a $150,000 WTP threshold. In Europe, it was favored below $1661.82/100 mg and $2501.93/100 mg for the same thresholds. In China, tislelizumab was cost-effective at a WTP threshold of $38,184 when priced below $582.11/100 mg. Conclusion: Tislelizumab presents a cost-effective first-line treatment option for uHCC, potentially supporting its broader adoption in health policy. Future research should focus on long-term efficacy and real-world data to further validate these findings. [ABSTRACT FROM AUTHOR]

Drug-induced hyponatremia is an adverse reaction with accelerated electrolyte disturbance. This study reported a rare case of delayed hyponatremia in a 68year-old female with recurrent upper tract urothelial carcinoma after Gemcitabine plus Cisplatin (GC) and Tislelizumab treatment. She had left ureter surgery, recurrence a year later with mildly abnormal kidney function (glomerular filtration rate (GFR) was 54.9 ml/min). After the first cycle of GC plus Tislelizumab, severe hyponatremia leading to life-threatening conditions occurred eight days later. Hypothesizing Cisplatin as the cause, its usage was modified in the second cycle (40mg/day for three days). No severe hyponatremia followed. CT showed partial remission. From the third cycle, due to grade IV bone marrow suppression, she had Tislelizumab alone. Now, she is on 21-day Tislelizumab maintenance with a stable tumor status. Low-dose continuous Cisplatin may suit patients with borderline or mildly abnormal renal function (GFR: 40-60mL/min) better than single full-dose use. Tislelizumab alone for maintenance may be an option for those intolerant of chemotherapy. But Na+ decrease may be related to Tirelizumab or Gemcitabine, needing more clinical observation and experiments. [ABSTRACT FROM AUTHOR]

Background: Malignant esophageal mediastinal fistula is a severe complication that occurs in both the advanced stages of esophageal cancer and after radiotherapy for esophageal cancer. Esophageal mediastinal fistula is very susceptible to complications such as mediastinitis and mediastinal abscess, resulting in a significantly elevated mortality rate for patients. We reported a rare case of esophageal mediastinal fistula after immunotherapy for non-small cell lung cancer (NSCLC). Case Presentation: A 74-year-old male patient with NSCLC was hospitalized in July 2023. About one week after Tislelizumab immunotherapy, the patient suddenly developed high fever accompanied by coughing and choking on water, chest tightness, shortness of breath, and hemoptysis. Following the completion of bronchial artery computed tomography angiography (CTA), imaging suggested the presence of esophageal mediastinal fistula. We opted for a conservative medical treatment instead of surgery. The patient was discharged without any complications. Conclusions: This is the first case of NSCLC accompanied by an esophageal mediastinal fistula after treatment with tislelizumab. The occurrence of malignant esophageal mediastinal fistula is very uncommon and poses a high level of hazard. In addition, this paper provides a concise overview of cases of lung cancer complicated with esophageal fistula in the past 10 years. It offers valuable insights for diagnosis and treatment, serving as a resource for clinicians. [ABSTRACT FROM AUTHOR]

Primary small cell neuroendocrine carcinoma of the prostate is extremely rare, highly aggressive, and has a very poor prognosis, with an overall survival typically not exceeding one year. Standard treatment is generally based on the regimen for small cell lung cancer (SCLC), with guidelines recommending etoposide combined with cisplatin (EP regimen) as the first-line treatment. However, their therapeutic effects are limited. For primary small cell neuroendocrine carcinoma of the prostate that has failed the EP regimen treatment, there is currently a lack of relevant treatment methods. Here, we report a case of small cell neuroendocrine carcinoma of the prostate with multiple metastases, whose disease rapidly progressed despite receiving EP and second-line systemic chemotherapy. The patient was then administered a combination of anlotinib and tislelizumab. After treatment, the patient's symptoms were controlled, tumor marker levels decreased, and imaging showed significant improvement. The patient had a progression-free survival time of more than 22 months and continued to receive treatment. This is the first report of the use of anlotinib combined with tislelizumab for the treatment of primary small cell neuroendocrine carcinoma of the prostate, providing a new therapeutic option for patients with this disease. [ABSTRACT FROM AUTHOR]

Background: Since the imported PD-1 inhibitor pembrolizumab was listed in China in 2018, China has opened up the era of immunotherapy for malignant tumors, with several domestically produced PD-1 inhibitors coming onto the market one after another. To find out whether there are differences in the efficacy and safety of domestic and imported PD-1 inhibitors in patients with advanced non-small cell lung cancer, we conducted this retrospective study in two tertiary hospitals in China. Methods: Patients with advanced NSCLC treated with tislelizumab or camrelizumab or pembrolizumab who met the inclusion criteria were screened through the electronic medical record system. A total of 259 patients were screened, but due to the unbalanced baseline, we performed propensity score matching and finally included 149 patients in three groups: pembrolizumab (n = 38), tislelizumab (n = 38), and camrelizumab (n = 73), which had very balanced baseline characteristics in each group after propensity score matching treatment. Results: The results showed that the median progression-free period was 11.3 m vs 10.1 m vs 8.9 m; p = 0.754; and the objective response rate was 63.2% vs 50% vs 57.5%; P = 0.510 for pembrolizumab, tislelizumab, and carrelizumab, respectively. There was no significant difference in median PFS between PD-L1 expression subgroups. In terms of safety, only skin toxicity of any grade of carrelizumab was higher than that of the other two groups (p = 0.034), and the incidence of grade ≥ 3 adverse reactions was not statistically significant among the three groups. Conclusion: In this real-world study, the efficacy and safety of the domestically produced tislelizumab, camrelizumab, and the imported pembrolizumab were comparable. [ABSTRACT FROM AUTHOR]

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Purpose: To assess the activity and toxicity of hepatic arterial infusion chemotherapy (HAIC)+tislelizumab+lenvatinib (HAIC+tisle+len) in hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) type IV (Vp4 hCC) in a real-world context. Methods: Fifty-five patients, with Vp4 hCC receiving HAIC+tisle+len therapy from April 2021 to December 2022, were analyzed retrospectively. Data on patient characteristics, adverse events (AEs), treatment, and survival were collected. Outcomes were disease control rate (DCR), overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and treatment-related AEs (TRAEs). Results: As of December 20, 2023, the median follow-up was 17.5 months (95% confidence interval [CI]: 14.7– 22.5). The ORR was 52.7% (3 complete response [CR], 26 partial response [PR]) as per RECIST v1.1 and 65.5% (12 CR, 24 PR) as per mRECIST. The DCR was 94.5% using both RECIST v1.1 and mRECIST. The median PFS and the median OS were 8.0 months (95% CI: 6.2– 12.3) and 16.7 months (95% CI: 12.0-not reached), respectively. Additionally, PFS was independently predicted only by the best tumor response. In patients with the best tumor response (PR or CR), the median PFS was 11.7 months (95% CI: 8.02-not reached) by mRECIST and 15.4 months (95% CI: 7.39-not reached) by RECIST v1.1. Hypertension (14.5%), decreased albumin levels (10.9%) and anorexia (9.1%) were the most frequently observed grade 3– 4 TRAEs. Conclusion: HAIC+tisle+len regimen demonstrated a promising efficacy and favorable safety for patients with HCC and Vp4, providing valuable real-world evidence to complement the trial data for Vp4 hCC. [ABSTRACT FROM AUTHOR]

The Phase 3 RATIONALE-312 trial (NCT04005716) showed that tislelizumab plus chemotherapy led to a noteworthy enhancement resulted in a significant improvement in overall survival among patients diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) compared to chemotherapy alone. The treatment also had an acceptable level of safety. Nevertheless, the debate over the efficacy of implementing several treatment plans in competition continues due to the significant expenses involved. Therefore, we aimed to evaluate the potential efficacy and cost of tislelizumab treatment as a first-line treatment for the ES-SCLC patient population in China. The study assessed primary health outcomes by measuring life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). This was done using a Markov model considering three health states with a 15-year horizon. To assess its model resilience, we conducted one-way sensitivity analyses with probability. In addition, subgroup analyses of some pre-specified patients was performed. Compared to chemotherapy alone, tislelizumab plus chemotherapy resulted in an additional 0.34 ($8,028) QALYs, leading to an ICER of $23,553 per QALY for the overall patient population. The ICER was lower than the assumed willingness-to-pay threshold of $35,367 per QALY. Approximately 60% of simulations suggested that tislelizumab in combination with chemotherapy was cost-effective, while 40% suggested that chemotherapy alone was cost-effective. The subsequent sensitivity analyses revealed that the health utility value associated with the disease progression parameter had the greatest influence on ICER. Tislelizumab plus chemotherapy was a preferable treatment option for regimens for patients with ES-SCLC in China. This finding is important in guiding the Chinese healthcare system. [ABSTRACT FROM AUTHOR]

Objective: The RATIONALE-305 trial demonstrated that tislelizumab in combination with chemotherapy regimens was more beneficial than chemotherapy regimens alone in the treatment of patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC). This study aimed to evaluate the cost-effectiveness of tislelizumab combination chemotherapy in the treatment of advanced GC/GEJC from the perspective of the Chinese health service system. Methods: A three-state partition survival model was constructed to evaluate the economics of tislelizumab combined with chemotherapy as the first-line treatment of advanced GC/GEJC. Clinical data were collected from the RATIONALE-305 trial, and the incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted life years (QALYs) as the output index. The stability of the results was verified using sensitivity and subgroup analyses. In addition, scenario analysis was conducted for the model simulation time and different parameter extrapolation models. Results: The results of basic analysis showed an increase of 0.31 QALYs in the tislelizumab group compared with the placebo group (1.53 QALYs vs 1.22 QALYs), and a concomitant increase in cost of 10,326.68 USD, with an ICER of 33,876.38 USD/QALY, which is less than the current Chinese willingness-to-pay threshold (36,924.80 USD/QALY). Sensitivity analyses demonstrated that the utility values of progression-free survival, progressive disease and the price of capecitabine had a greater impact on the model. Subgroup analysis revealed that combination therapy was equally cost-effective in people with a program death ligand 1 tumor area positivity score of ≥5%. Conclusion: From the perspective of the Chinese health service system, the treatment of advanced GC/GEJC with tislelizumab combined with chemotherapy has a cost-effective advantage over chemotherapy alone. [ABSTRACT FROM AUTHOR]

Although concurrent Chemoradiotherapy (cCRT) is presently the standard intervention for patients with inoperable, locally advanced Esophageal Squamous Cell Carcinoma (ESCC), it has been associated with poor long-term survival outcomes. Notably, Immune Checkpoint Inhibitors (ICIs) improve the long-term survival of Esophageal Cancer (EC) patients, with manageable Adverse Effects (AEs). Herein, 90 patients with residual pathology after radical simultaneous Radiotherapy (RT) for inoperable/refused-to-operate ESCC were enrolled and randomized into two treatment groups (Chemotherapy+immunotherapy and chemotherapy alone) in a 2:1 ratio. This study will also discuss the value of immunotherapy in improving long-term survival outcomes in patients with pathological residuals after concurrent RT for locally advanced, inoperable ESCC. Clinical trial registration: http://www.chictr.org.cn/identifier is ChiCTR2200063345. [ABSTRACT FROM AUTHOR]

Background: The application of neoadjuvant immunotherapy in the treatment of esophageal cancer needs further exploration. This study aimed to investigate the safety and effectiveness of tislelizumab, an anti-PD-1 antibody, combined with chemotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma (LA-ESCC). Methods: In this phase II study, patients with clinical stages of II-IVA (T3-T4 and/or node positive) potentially resectable LA-ESCC were enrolled. Patients received neoadjuvant tislelizumab and chemotherapy every 3 weeks for 4 cycles before surgery and adjuvant tislelizumab for 9 months. The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints included R0 resection, disease free survival (DFS), adverse events (AE), and biomarkers for predicting efficacy. Results: The study included 30 patients. 25 patients completed neoadjuvant chemoimmunotherapy and underwent surgery, 96% with R0 resection. The pCR and MPR rate was 44% and 52%. The 6-month and 1-year DFS rate was 100% and 75.3%. 43.3% patients experienced severe (grade 3-4) treatment-related adverse events (TRAEs) and 5 patients developed severe immune-related adverse events (irAEs). Further exploration found that a group of peripheral lymphocyte subsets increased significantly after 2 cycles of neoadjuvant therapy in patients who achieved pCR, suggesting the importance of dynamic monitoring of circulating lymphocyte. Conclusions: The combination of perioperative tislelizumab and neoadjuvant chemotherapy has achieved an encouraging pCR rate and demonstrated a manageable safety profile in patients with potentially resectable ESCC. Clinical Trial Registration: https://www.chictr.org.cn/ , identifier ChiCTR2100043772. [ABSTRACT FROM AUTHOR]

Tislelizumab, as a PD-1 inhibitor, has demonstrated significant efficacy in cancer treatment. However, it may also induce immune-related adverse events (irAEs). This case report describes a patient who developed oral ulcers and dysphagia following treatment with tislelizumab, which was diagnosed as exfoliative esophagitis through endoscopic examination. The condition improved after corticosteroid pulse therapy. A review of the relevant literature revealed no prior reports of immune checkpoint inhibitor (ICI)-related esophagitis cases, prompting an exploration of the potential pathophysiological mechanisms and therapeutic strategies. This report emphasizes the importance of vigilance for rare irAEs during ICI therapy, advocating for early detection and timely intervention. [ABSTRACT FROM AUTHOR]

This case report highlights the immune-related adverse events (irAEs) that occurred during the treatment of esophageal cancer with Tislelizumab and discusses management strategies, indicating that photodynamic therapy (PDT) may be an optimal adjunctive treatment option. Following Tislelizumab therapy, the patient demonstrated significant tumor reduction; however, subsequent irAEs related to immunotherapy emerged, including eyelid muscle weakness and myocardial and skeletal muscle injury. Methylprednisolone successfully alleviated these symptoms, with early intervention being crucial for controlling irAEs. The patient then underwent PDT, which not only further helped manage irAEs but also inhibited tumor progression. This case underscores the specific adverse reactions, such as eyelid ptosis, skeletal muscle, and myocardial damage associated with Tislelizumab, and the importance of early corticosteroid intervention. It also emphasizes the significance of PDT as an adjunctive treatment for controlling tumors and alleviating immune-related adverse reactions. [ABSTRACT FROM AUTHOR]

Purpose: The efficacy of tislelizumab plus chemotherapy in improving progression-free survival (PFS) and overall survival (OS) in unresectable gastric or gastroesophageal junction cancer (GC/GEJC) has recently been emphasized. This study compared the cost-effectiveness of tislelizumab plus chemotherapy versus placebo plus chemotherapy for the United States (US) and Chinese populations. Methods: Using data from the RATIONALE-305 phase 3 trial, a Markov model was developed to analyze quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), incremental net health benefits (INHBs), and incremental net monetary benefits (INMBs). The health state utilities and direct medical costs were obtained from the relevant literature and local cost databases. The model uncertainty was evaluated using sensitivity analyses. Findings: In the base-case analysis, the addition of tislelizumab to chemotherapy yielded an ICER of $37,768.48 per QALY in China, slightly below the willingness-to-pay (WTP) threshold of $38,042.49 per QALY, showing marginal cost-effectiveness with an INHB of 0.05 QALYs and an INMB of $1,852.49. Subgroup analyses revealed ICERs of $23,853.52 for patients with a PD-L1 TAP score ≥ 5% (TAP ≥ 5%). In the US, the ICER was $502,786.22 per QALY in the intent-to-treat (ITT) and $321,395.28 per QALY in the TAP ≥ 5% subgroup, exceeding the US WTP threshold of $150,000.00. Implications: In China, tislelizumab plus chemotherapy is a cost-effective first-line therapy for unresectable GC/GEJC in both ITT and TAP ≥ 5% subgroups. In the US, tislelizumab plus chemotherapy is not cost-effective. [ABSTRACT FROM AUTHOR]

Background and Aim: Shipixiaoji granules (SPXJ) is traditional Chinese medicine that treats hepatocellular carcinoma (HCC). However, its efficacy in HCC is still unknown. This prospective study assessed the outcomes of using SPXJ combined with tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) in the management of patients with unresectable HCC. Methods: This study was conducted as a single-arm phase II clinical trial. We recruited patients diagnosed with CNLC stage Ⅱ to Ⅲ HCC. The treatment regimen included oral lenvatinib (12 mg for patients weighing ≥60 kg; 8 mg for those weighing <60 kg) once daily, intravenous tislelizumab (200 mg) every 3 weeks, and SPXJ twice daily. The primary endpoint was defined as progression-free survival (PFS) in accordance with RECIST 1.1 criteria. Results: Fifty-four patients were enrolled in this study. The primary endpoint was achieved, with a median PFS of 12.7 months. The objective response rate (ORR) was recorded at 55.6%. The disease control rate (DCR) was observed at 98.1%. Additionally, we compared PFS based on the participants' sleep behavior. The results indicated that patients with a morning chronotype had a median PFS of 14.1 months, while those with a night chronotype had a median PFS of 9.85 months (95% CI: 1.366-6.853, P <.05). Treatment-related adverse events were reported in 96.3% (n = 52) of patients. Conclusions: The combination of SPXJ, lenvatinib, and tislelizumab demonstrated substantial safety and anti-tumor efficacy as first-line treatment for unresectable HCC. Moreover, patients' sleep behavior significantly influences treatment efficacy. [ABSTRACT FROM AUTHOR]

Purpose: We aimed to explore the curative effects of hepatic arterial infusion chemotherapy (HAIC) combined with Tislelizumab and Lenvatinib on unresectable hepatocellular carcinoma (HCC). Patients and methods: From September 2021 to September 2023, 42 patients with unresectable HCC who were treated in the First Affiliated Hospital of Chongqing Medical University were enrolled in this retrospective single-arm study. They received HAIC combined with Tislelizumab and lenvatinib. Baseline characteristics, laboratory indicators before and after treatment, and imaging findings were collected from medical records. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety indicators. Results: A total of 199 HAIC treatments were performed, with a median of 5.5 times (3.75–6.0 times). Based on the mRECIST and RECIST1.1 criterion, the ORR was 71.4% and 57.1%, the DCR was 92.9% and 92.9%. Up to the follow-up date of October 1, 2024, the median PFS was 14.0 months (95% CI, 11.6–16.4 months), and the median OS was 26.0 months.The incidence of any grade of adverse events was 97.6%. The most commonly reported treatment-related grade 3–4 adverse events included thrombocytopenia (28.6%), elevated total bilirubin (19%), and abdominal pain (16.7%). There was no treatment-related death. Conclusion: For unresectable HCC, HAIC combined with tirelizumab and lenvatinib has good anti-tumor efficacy and acceptable adverse reactions. [ABSTRACT FROM AUTHOR]

Background: Tislelizumab combined with chemotherapy has shown significant clinical benefits in improving overall survival compared to chemotherapy alone for patients with extensive-stage small-cell lung cancer (ES-SCLC). Aim: This study aimed to evaluate the cost-effectiveness of tislelizumab plus chemotherapy versus standard chemotherapy as a first-line treatment for ES-SCLC from the US payer perspective and the perspective of the Chinese healthcare system. Method: We conducted an economic evaluation using a Markov state-transition model, reflecting the US payer perspective and the perspective of the Chinese healthcare system. Baseline patient characteristics and essential clinical data were obtained from the RATIONALE-312 trial. The costs and utilities were derived from open-access databases and published literature. The primary outcomes measured included quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB). Uncertainties in the model were addressed by probabilistic sensitivity analysis (PSA) and one-way sensitivity analysis (OWSA). Results: In the base-case analysis, the addition of tislelizumab to chemotherapy provided an incremental gain of 0.16 QALYs at an additional cost of $7430.73, resulting in an ICER of $46,132.33 per QALY. Although above the willingness-to-pay (WTP) threshold of China of $38,042.49 per QALY, the cost-effectiveness was marginal, with an INHB of − 0.03 QALYs and an INMB of $− 1303.06. In the US, despite a slightly higher effectiveness gain of 0.28 QALYs, the increased cost of $45,157.35 resulted in an unfavorable ICER of $163,885.06 per QALY, exceeding the US WTP threshold of $150,000.00. PSA showed probabilities of cost-effectiveness of tislelizumab plus chemotherapy at 17.18% in China and 40.41% in the US. Conclusion: Tislelizumab combined with chemotherapy was not a cost-effective first-line treatment option for ES-SCLC in China or the US; however, the margin of cost-effectiveness was narrow. [ABSTRACT FROM AUTHOR]

Background: This study reported the safety and efficacy of a phase 2, open-label, single-arm, exploratory clinical trial of induction immunochemotherapy in patients with initially unresectable advanced esophageal squamous cell carcinoma (ESCC). Patients and Methods: Patients underwent three cycles of induction therapy with tislelizumab, cisplatin, and 5-fluorouracil. The primary endpoints were the safety, major pathological response (MPR), and pathological complete response (pCR). Secondary endpoints included the R0 resection rate, disease-free survival (DFS), and overall survival (OS). Genomic data and immune microenvironment data were analyzed exploratively. Results: The treatment was safe, with a grade 3 or higher adverse event rate of 14.9% (7/47). Of the total 47 patients enrolled in the study, 19 (40.4%) achieved MPR, 12 (25.5%) achieved pCR, 4 (8.5%) achieved complete clinical response (cCR) and declined surgery, and 23 (48.94%) underwent successful resection. Median follow-up was 18 months, with a median DFS of 24 months, a median OS of 36 months. A high tumor mutation burden was associated with a better prognosis for patients who underwent surgery. Patients who achieved pCR had higher levels of immune cell infiltration and a greater proportion and concentration of tertiary lymphoid structures compared with those who experienced a major pathological response. Conclusions: Tislelizumab combined with chemotherapy is effective for ESCC, yielding high cCR, pCR, surgical conversion, and R0 resection rates, and tolerable adverse events. Trial Registration: NCT05469061. [ABSTRACT FROM AUTHOR]

Introduction: Gemcitabine and cisplatin remain the cornerstone for the treatment of advanced or unresectable biliary tract cancers, but the incidence rate of the grade 3 or 4 toxic effects is high (70.7%). In recent years, significant progress has been achieved in the systemic treatment of cholangiocarcinoma with immune checkpoint inhibitors (ICIs), targeted therapy, and hepatic artery infusion chemotherapy (HAIC). HAIC may elevate the local drug concentration in the liver to 10–100 times the drug plasma concentration; therefore, it may enhance tumor cytotoxicity while minimizing systemic adverse effects. HAIC combined with immunotherapy and targeted therapy resulted in acceptable tumor responses and tolerable toxic effects in the treatment of hepatocellular carcinoma (HCC). However, whether this combination strategy can benefit patients with unresectable intrahepatic cholangiocarcinoma remains unclear. Methods and Analysis: We describe a single-arm, open label, prospective clinical trial of HAIC sequential transcatheter arterial embolization (TAE) combined with tislelizumab and surufatinib in patients with unresectable intrahepatic cholangiocarcinoma. TAE + HAIC was performed at an interval of at least 3 weeks, and oxaliplatin (85 mg/m2) and rituximab (3 mg/m2) were infused. TAE was performed using undrugged microspheres. Tislelizumab was infused every 3 weeks and surufatinib was administered orally once a day, with 3-5 capsules (50 mg/capsule) each time. We plan to enroll 28 participants in this study. The primary study endpoint was objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), conversion to surgical resection rate, overall survival (OS), 1-year OS rate, disease control rate (DCR), quality of life (QoL), and incidence of adverse events. Trial registration number: NCT06239532. [ABSTRACT FROM AUTHOR]

Abstract In renal cell carcinoma (RCC) patients with inferior vena cava (IVC) tumor thrombus, neoadjuvant therapy could alleviate the burden of tumor thrombus, enhance the safety and feasibility of surgical resection, and improve patient prognosis. The combination of tislelizumab and axitinib has demonstrated efficacy in the treatment of advanced RCC. Our study aimed to evaluate the efficacy and safety in the neoadjuvant therapy setting of tislelizumab and axitinib in RCC patients with IVC tumor thrombus. In this retrospective study, seven patients of nonmetastatic RCC with IVC tumor thrombus who received 3 cycles of neoadjuvant therapy with tislelizumab plus axitinib at the First Affiliated Hospital of Xiamen University from May 2020 to December 2023 were included. The main outcomes included objective response rate (ORR), reduction of tumor thrombus size and level, surgical outcomes, and adverse events (AEs). The median age was 66 (range, 50–72) years, and five (71.4%) patients were male. Five (71.4%) patients were diagnosed with clear cell carcinoma, and two (28.6%) patients were papillary type I carcinoma. Four (57.1%) patients had level II tumor thrombus and three (42.9%) patients had level III. The ORR of patients was 57.1%. The mean decrease in thrombus diameter and length was 5.8 (1.8–17.2) mm and 18.5 (4.4–41.5) mm, respectively. All patients showed a decrease in IVC tumor thrombus. The mean time from the end of neoadjuvant therapy to radical nephrectomy and thrombectomy was 31.7(range, 22–45) days. No intraoperative complications or postoperative Clavien-Dindo grade>3 complications occurred. The most common AEs were all grade 1–2, and only one patient had grade 4 hepatic impairment. No AEs delayed the surgery schedule. This study of RCC patients receiving neoadjuvant combination with tislelizumab and axitinib effectively reduced primary tumor and IVC tumor thrombus with the absence of serious AEs, demonstrating a promising neoadjuvant therapy.