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

Last updated: September 10, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Digestive System Neoplasms

Gastric Cancer

Stomach Cancer

Treatment

Capecitabine

Oxaliplatin

Apatinib

Clinical Study ID

NCT03813784
SHR-1210-III-311
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has histologically- or cytologically-confirmed diagnosis of locally advancedunresectable or mestastatic adenocarcinoma of stomach or the esophagogastricjunction (GEJ)

  • Age ≥ 18 years old, male or female

  • NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER-2inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.

  • Has measurable disease per RECIST 1.1

  • Eastern Cooperative Group (ECOG) performance status of 0 to 1

  • Has adequate organ function

  • Females of childbearing potential (FOCBP), who are not surgically sterile orpostmenopausal, must conduct pregnancy test (serum or urine) within 7 days beforeenrollment, and must not be pregnant or breast-feeding women. If the result isnegative, she must agree to use adequate contraception during the experiment and 3months after the last administration of the test drugs. And non-sterilized males whoare sexually active must agree to use adequate contraception during the experimentand 3 months after the last administration of the test drugs.

Exclusion

Exclusion Criteria:

  • Has known HER2-positive status

  • Has known active central nervous system metastatases

  • Has received a live vaccine within 4 weeks prior to the first dose of studytreatment

  • With any acitve autoimmune disease or history of autoimmune disease, including butnot limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism,and hypothyroidism, except for subjects with vitiligo or resolved childhoodasthma/atopy. Asthma that requires intermittent use of bronchodilators or othermedical intervention should also be excluded.

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody,or a VEGFR inhibitor.

  • Clinically significant cardiovascular and cerebrovascular diseases, including butnot limited to severe acute myocardial infarction within 6 months before enrollment,unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), orventricular arrhythmia which need medical intervention.

  • Hypertension and unable to be controlled within normal level following treatment ofanti-hypertension agents: systolic blood pressure > 140 mmHg, diastolic bloodpressure > 90 mmHg.

Study Design

Total Participants: 885
Treatment Group(s): 4
Primary Treatment: Capecitabine
Phase: 3
Study Start date:
March 07, 2019
Estimated Completion Date:
June 07, 2023

Connect with a study center

  • Beijing Cancer Hospital, Peking University

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Cancer Hospital, Peking University

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

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