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

NCT03813784 | Completed Phase 3 DMC

• 1 other identifier: SHR-1210-III-311
• Study Type: interventional
• Target: 885
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; GastroEsophageal Cancer

Keywords

PD-1; SHR-1210

Outcome Measures

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

  Up to 36 months after the first participant is randomized.

Secondary Outcomes (8)

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

  Up to approximately 36 months.

• Progression-free Survival (PFS) per RECIST 1.1

  Up to approximately 36 months.

• Incidence and severity of adverse events (AEs)

  Up to approximately 36 months.

• Incidence and severity of serious adverse events (SAEs)

  Up to approximately 36 months.

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

  Up to approximately 12 months, 18 months and 24 months.

Study Arms (3)

A

EXPERIMENTAL

Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m\^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m\^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 250 mg PO qd.

Drug: SHR-1210; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Apatinib

B

ACTIVE COMPARATOR

Capecitabine 1000 mg/m\^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus Oxaliplatin 130 mg/m\^2, IV q3w

Drug: Capecitabine; Drug: Oxaliplatin

C

EXPERIMENTAL

Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m\^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m\^2, IV q3w; for 4-6 cycles followed by SHR-1210

Drug: SHR-1210; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

SHR-1210 DRUG

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

A; C

Capecitabine DRUG

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

A; B; C

Oxaliplatin DRUG

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

A; B; C

Apatinib DRUG

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital, Peking University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; Capecitabine; Oxaliplatin; apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 23, 2019
• Study Start: March 7, 2019
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)