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A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Summary
This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study,the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
Official title: A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
737
Start Date
2021-12-06
Completion Date
2025-10-01
Last Updated
2025-03-30
Healthy Volunteers
No
Interventions
SHR-1701、CAPOX
SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine)
Placebo、CAPOX
Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)
Locations (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China