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

NCT04950322 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 737

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SHR-1701、CAPOX

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

DRUG

Placebo、CAPOX

Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2024-05-20
Completion
2025-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950322 on ClinicalTrials.gov