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ACTIVE NOT RECRUITING
NCT04950322
PHASE3

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

Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

SHR-1701、CAPOX

SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

DRUG

Placebo、CAPOX

Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China