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A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

NCT03472365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-01-11

Study results available
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Summary

The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

Interventions

BIOLOGICAL

SHR-1210

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

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

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Shen, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2020-11-25
Completion
2020-11-25

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 NCT03472365 on ClinicalTrials.gov