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Wanren Peng,1,* Fenglin Zhang,2,* Zishu Wang,3,* Dongliang Li,4,* Yifu He,5,* Zhongliang Ning,6 Lili Sheng,7 Jidong Wang,8 Xiaoyang Xia,9 Changjun Yu,10 Zian Wang,3 Yong Zhao,11 Hui Liang,12 Bing Hu,13 Cuiling Sun,14 Daoqin Wang,15 Yunsheng Cheng,16 Ming Pan,17 Liming Xia,18 Xinglai Guo,19 Yanshun Zhang,20 Zhiqiang Hu,21 Xinzhong Li,22 Lin Lu,23 Jun Zhang,24 Hong Qian,8 Hua Xie,25 Guoping Sun1,* 1Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, People’s Republic of China; 2Department of Oncology, People’s Hospital of Maanshan City, Maanshan, Anhui 243000, People’s Republic of China; 3Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, People’s Republic of China; 4Department of Gastrointestinal Surgery, People’s Hospital of Lu’an City, Lu’an, Anhui 237005, People’s Republic of China; 5Department of Oncology, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital), Hefei, Anhui 230022, People’s Republic of China; 6Department of Gastrointestinal Surgery, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital), Hefei, Anhui 230022, People’s Republic of China; 7Department of Oncology, Yijishan Hospital of WanNan Medical College, Wuhu, Anhui 340202, People’s Republic of China; 8Department of Oncology, The Navy Anqing Hospital, Anqing, Anhui 246003, People’s Republic of China; 9Department of Oncology, The First People’s Hospital of Chuzhou City, Chuzhou, Anhui 239000, People’s Republic of China; 10Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, People’s Republic of China; 11Department of Oncology, People’s Hospital of Lu’an City, Lu’an, Anhui 237005, People’s Republic of China; 12Department of Oncology, Lu’an Hospital of Traditional Chinese Medicine, Lu’an, Anhui 237006, People’s Republic of China; 13Department of Oncology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui 230022, People’s Republic of China; 14Department of Oncology, People’s Hospital of Fuyang City, Fuyang, Anhui 236047, People’s Republic of China; 15Department of Gastrointestinal Surgery, Wanbei Coal-Electricity Group General Hospital, Suzhou, Anhui 234000, People’s Republic of China; 16Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230601, People’s Republic of China; 17Department of Oncology, People’s Hospital of Chizhou City, Chizhou, Anhui 247000, People’s Republic of China; 18Department of Oncology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui 230031, People’s Republic of China; 19Department of Oncology, Fuyang Cancer Hospital, Fuyang, Anhui 236033, People’s Republic of China; 20Department of Oncology, Huainan First People’s Hospital, Huainan, Anhui 232000, People’s Republic of China; 21Department of Oncology, Huaibei Miners General Hospital, Huaibei, Anhui 235000, People’s Republic of China; 22Department of Oncology, People’s Hospital of Huaibei, Huaibei, Anhui 235000, People’s Republic of China; 23Department of Oncology, The 901 Hospital of the Joint Logistic Support Force of the People’s Liberation Army of China, Hefei, Anhui 230033, People’s Republic of China; 24Department of Oncology, The Second People’s Hospital of Wuhu, Wuhu, Anhui 241001, People’s Republic of China; 25Department of Oncology, The People’s Hospital of Xuancheng City, Xuancheng, Anhui 242000, People’s Republic of China*These authors contributed equally to this workCorrespondence: Guoping Sun Email sungp@ahmu.edu.cnBackground: In China, gastric cancer (GC) ranks second in incidence and mortality. Over 80% of patients with GC were diagnosed at an advanced stage with poor clinical outcome. Chemotherapy was the mainstream treatment with limited benefit. Apatinib, an inhibitor of targeting vascular endothelial growth factor receptor 2 (VEGFR2), has been approved for third-line treatment of advanced gastric cancer. However, the data of apatinib treatment in the real-world setting are limited. In this real-world study, we aimed to understand the current treatment pattern of apatinib, investigate the effectiveness and safety of apatinib in real-world settings, and explore the potential factors associated with the clinical outcomes.Methods: This was a prospective, multicenter observational study in a real-world setting. Patients aged ≥ 18 years with histologic diagnosis of advanced GC were eligible for enrollment. The eligible patients received either apatinib monotherapy or apatinib plus chemotherapy by physician’s discretion. Apatinib treatment could be used as first-line, second-line, or third-line and above therapy. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), ORR, DCR, and safety profile.Results: A total of 737 patients with advanced gastric cancer treated with apatinib were included in the FAS population. A total of 54.9% patients used apatinib monotherapy and 45.1% patients used apatinib combination therapy. A total of 44.1% patients received apatinib in first-line treatment, 28.2% in second-line, and 27.7% in third-line and above. In first-line treatment, the objective response rate (ORR) was 9.09% and 16.42% in apatinib monotherapy and combination therapy groups, and disease control rate (DCR) was 78.41% and 89.29%, respectively. Patients who received combination therapy achieved significantly longer median progression-free survival (mPFS; 6.18 vs 3.52 months, p< 0.01) and median overall survival (mOS; 8.72 vs 5.92 months, p< 0.01) compared with monotherapy. In second-line and third-line therapy, combination therapy showed a better trend in tumor response and survival outcomes compared with monotherapy. For all patients, apatinib combined with paclitaxel were associated with longer mPFS compared with other combinations (8.88 vs 6.62 months). Multivariate analysis showed that combination with paclitaxel (p=0.02) and experience of apatinib-related specific AEs (p< 0.01) were independent predictors for PFS and OS. The safety profile was tolerable and no unexpected adverse events were reported.Conclusion: In a real-world setting, apatinib showed a favorable effectiveness and safety profile in patients with advanced gastric cancer. Apatinib combination therapy, especially combined with paclitaxel, might lead to better survival benefit in first-line treatment. Combination with paclitaxel and the occurrence of apatinib-specific AEs were independent factors associated with better survival outcomes.Trial Registration: NCT03333967.Keywords: apatinib, combination therapy, real-world, advanced gastric cancer