研究单位：[1]Shanghai Henlius Biotech[2]Peking University International Hospital Beijing, Beijing, China, 102206[3]The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing, China, 400042[4]the 900th Hospital of Joint Logistic Support Force Fuzhou, Fujian, China, 35002[5]Zhongnan Hospital of Wuhan University Wuhan, Fujian, China, 430062[6]The First Affiliated Hospital of Xiamen University Xiamen, Fujian, China, 361003[7]First People's Hospital of Fushan Fushan, Guangdong, China, 528010[8]The First Affiliated Hospital and Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou, Guangdong, China, 510075[9]The First Affiliated Hospital (School of Clinical Medicine), Guangdong Pharmaceutical University Guangzhou, Guangdong, China, 510080[10]Affiliated Cancer Hospital & Institute, Guangzhou Medical University Guangzhou, Guangdong, China, 510095[11]the Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China[12]Affiliated Hospital of Guangdong Medical University Zhenjiang, Guangdong, China, 510180[13]Zhongshan city People's Hospital Zhongshan, Guangdong, China, 528404[14]The Fifth Affiliated Hospital, Sun Yat-sen University Zhuhai, Guangdong, China, 519000[15]The People's Hospital of Guangxi Zhuangzu Autonomous Region Nanning, Guangxi, China, 530016[16]Fourth Hospital of Hebei Medical University, Shijia Zhuang, Hebei, China, 050011河北医科大学第四医院[17]Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China, 150040[18]The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450052[19]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei, China, 200065[20]The Third Xiangya Hospital, Central South University Changsha, Hunan, China, 410013[21]Hunan Cancer Hospital Changsha, Hunan, China, 410031[22]Qinhuai Medical District, General Hospital of the eastern theater of the Chinese people's Liberation Army Nanjing, Jiangsu, China, 210002[23]The Second Affiliated Hospital of Dalian Medical University Dalian, Liaoning, China, 116023[24]Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute Shenyang, Liaoning, China, 110042[25]Qilu Hospital of Shandong University Jinan, Shandong, China, 250012[26]Shandong Cancer Hospital Jinan, Shandong, China, 250117[27]Shanghai East Hospital Shanghai, Shanghai, China, 200120[28]Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China Chengdu, Sichuan, China, 610041[29]West China Hospital, Sichuan University Chengdu, Sichuan, China, 610041[30]Tianjin Medical University Cancer Institue and Hospital Tianjin, Tianjin, China, 300060[31]Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center Kunming, Yunnan, China, 650118[32]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022[33]Taizhou first people's Hospital Taizhou, Zhejiang, China, 318020[34]The Second Affiliated Hospital of Anhui Medical University Hefei, Anhui, China, 230601
研究目的：
It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX10 (3 mg/kg) once every 2 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol, or up to the longest treatment duration-2 years (52 dosing periods) (whichever occurs earlier).
