Spots Global Cancer Trial Database for A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC
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Trial Identification
Brief Title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC
Official Title: An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Study ID: NCT05221658
Study Description
Brief Summary: 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital Chinese Academic of Medical Sciences, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Cancer Hospital Chinese Academic of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, China
Anyang Cancer Hospital, Anyang, Hebei, China
Xingtai People's Hospital, Xingtai, Hebei, China
Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhenzhou, Henan, China
Hunan Cancer Hospitla, Changsha, Hunan, China
Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu People Hospital & The First Affiliated with Nanjing Medical University, Nanjing, Jiangsu, China
Xuzhou Center Hospital, Xuzhou, Jiangsu, China
Shandong Cancer Hospital, Jinan, Shandong, China
Affiliated Hospital of Jining Medical University, Jining, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanxi Cancer Hospital, Taiyuan, Shanxi, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center, Kunming, Yunnan, China
Contact Details
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