研究单位:[1]Shanghai Henlius Biotech[2]Cancer Hospital Chinese Academic of Medical Sciences,Beijing,Beijing,China[3]Fujian Cancer Hospital,Fuzhou,Fujian,China[4]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China[5]Cancer Hospital Chinese Academic of Medical Sciences, Shenzhen Center,Shenzhen,Guangdong,China[6]Anyang Cancer Hospital,Anyang,Hebei,China[7]Xingtai People's Hospital,Xingtai,Hebei,China[8]Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University,Zhenzhou,Henan,China[9]Hunan Cancer Hospitla,Changsha,Hunan,China[10]Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital,Nanjing,Jiangsu,China[11]Jiangsu People Hospital & The First Affiliated with Nanjing Medical University,Nanjing,Jiangsu,China[12]Xuzhou Center Hospital,Xuzhou,Jiangsu,China[13]Shandong Cancer Hospital,Jinan,Shandong,China[14]Affiliated Hospital of Jining Medical University,Jining,Shandong,China[15]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China[16]Shanxi Cancer Hospital,Taiyuan,Shanxi,China[17]Sichuan Cancer Hospital,Chengdu,Sichuan,China[18]Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center,Kunming,Yunnan,China
研究目的:
This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score < 200) will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).