Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04342910

Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-01-20

550

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

CONDITIONS

Official Title

Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis confirmed by tissue or cytology as gastric or gastroesophageal junction adenocarcinoma
  • Metastatic or locally advanced disease that cannot be removed by surgery
  • Disease progressed after first-line therapy containing platinum/fluoropyrimidine or platinum/taxane
  • Willingness to provide tumor tissue for PD-L1 testing
  • Known HER-2/neu status; if positive, prior trastuzumab treatment documented
  • ECOG performance status 0 to 1
  • Life expectancy greater than 12 weeks
  • Signed informed consent forms
  • Adequate bone marrow, liver, and kidney function
Not Eligible

You will not qualify if you...

  • Squamous cell or undifferentiated gastric cancer
  • Active central nervous system metastases or carcinomatous meningitis
  • Active or suspected autoimmune disease, except stable type I diabetes on insulin, hypothyroidism on hormone therapy, or controlled skin diseases without recent worsening
  • Significant cardiovascular or cerebrovascular diseases
  • Uncontrolled high blood pressure
  • Digestive tract bleeding history within 3 months or bleeding tendency
  • Arterial or venous thrombosis events within 6 months before randomization
  • Previous treatment with anti-PD-1/PD-L1, anti-CTLA-4 antibodies, or VEGFR inhibitors
  • Chemotherapy, radiotherapy, or surgery within 4 weeks before study drug administration
  • Unresolved adverse events greater than CTCAE Grade 1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital, Academy of Military Medical Sciences

Beijing, China

Actively Recruiting

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Research Team

Q

Quanren Wang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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