Spots Global Cancer Trial Database for A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
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Trial Identification
Brief Title: A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Official Title: A Randomized, Double-blind, Multicenter, Phase III Clinical Trial Comparing HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Study ID: NCT03958890
Conditions
Study Description
Brief Summary: This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients.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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ethics Committeeof cancer hospital, Chinese academy of medical sciences,, Beijing, Beijing, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
Affiliated Tumor Hospital of Harbin Medical University, Ha'erbin, Heilongjiang, China
The first Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
the affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
the second Hospital of Jilin University, Changchun, Jilin, China
Contact Details
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