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A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy

NCT03813784 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 885

Last updated 2025-09-16

No results posted yet for this study

Summary

This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

Interventions

DRUG

SHR-1210

Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial

DRUG

Capecitabine

1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.

DRUG

Oxaliplatin

130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.

DRUG

Apatinib

250 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2023-06-07
Completion
2023-06-07

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT03813784 on ClinicalTrials.gov