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

NCT ID: NCT03813784

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 885 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2023-06-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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.

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Apatinib

Intervention Type: DRUG

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

B

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

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

C

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

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Interventions

SHR-1210

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Apatinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital, Peking University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

SHR-1210-III-311

Identifier Type: -

Identifier Source: org_study_id