A Study to Evaluate SHR-1210 in Combination With Capecitabine + Oxaliplatin Sequenced by SHR-1210 + Apatinib as First-line Therapy in Treatment of Advanced Gastric Cancer

Last updated: November 7, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Stomach Cancer

Gastric Cancer

Digestive System Neoplasms

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 apatinib with or without SHR-1210 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

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