Clinical Trial

A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-07-01; most recent amendment 2025-03-28.
Status change: Recruiting → Active, Not Recruiting 2024-02-06
Status change: Not Yet Recruiting → Recruiting 2021-12-14
Trial Details
NCT Number NCT04950322
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Gastric or Gastroesophageal Junction Cancer
Enrollment 737 participants
Start Date 2021-12-06
Primary Completion 2024-05-20 (estimated)
Study Completion 2025-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-30