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Completed

NCT Number: NCT03813784

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital, Peking University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or mestastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ)
  • Age ≥ 18 years old, male or female
  • NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER-2 inhibitor). 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 or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.

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 study treatment
  • With any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical 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 but not 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 of anti-hypertension agents: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.

Treatment and study plan

SHR-1210

Drug

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

Capecitabine

Drug

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

Oxaliplatin

Drug

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

apatinib

Drug

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

Primary outcomes

  1. Overall survival (OS) of SHR-1210 in combination with capecitabine + oxaliplatin sequenced by SHR-1210+apatinib versus capecitabine + oxaliplatin in all subjects or programmed cell death ligand 1 (PD-L1) positive participants

    Time frame: Up to 36 months after the first participant is randomized.

Secondary outcomes

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Time frame: Up to approximately 36 months.

  2. Progression-free Survival (PFS) per RECIST 1.1

    Time frame: Up to approximately 36 months.

  3. Incidence and severity of adverse events (AEs)

    Time frame: Up to approximately 36 months.

  4. Incidence and severity of serious adverse events (SAEs)

    Time frame: Up to approximately 36 months.

  5. Overall survival (OS) rates at 12 months, 18 months and 24 months

    Time frame: Up to approximately 12 months, 18 months and 24 months.

  6. Progression-free Survival (PFS) rates at 6 months

    Time frame: Up to approximately 6 months.

  7. Disease Control Rate (DCR) per RECIST 1.1

    Time frame: Up to approximately 36 months.

  8. Duration of Response (DoR) per RECIST 1.1

    Time frame: Up to approximately 36 months.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multi-center Phase III 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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