Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

NCT ID: NCT04342910

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2026-09-01

Brief Summary

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

camrelizumab (SHR-1210) combined with apatinib

Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.

Group Type: EXPERIMENTAL

camrelizumab

Intervention Type: DRUG

200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.

Apatinib Mesylate

Intervention Type: DRUG

250 mg qd

Paclitaxel or Irinotecan

Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Irinotecan

Intervention Type: DRUG

180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.

Interventions

camrelizumab

200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.

Intervention Type: DRUG

Apatinib Mesylate

250 mg qd

Intervention Type: DRUG

Paclitaxel

80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Intervention Type: DRUG

Irinotecan

180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.

Intervention Type: DRUG

Other Intervention Names

SHR-1210

Eligibility Criteria

Inclusion Criteria

1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.

2. Confirmed metastatic or locally advanced, unresectable disease.

3. Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.

4. Willing to provide tumor tissue for PD-L1 biomarker analysis.

5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.

6. ECOG performance status of 0 to 1.

7. Life expectancy of more than 12 weeks.

8. Signing the informed consent forms.

9. Adequate bone marrow, liver and renal function.

Exclusion Criteria

1. Squamous cell or undifferentiated gastric cancer.

2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

3. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.

4. Clinically significant cardiovascular and cerebrovascular diseases.

5. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.

6. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.

7. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.

8. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

9. Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.

• 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

Principal Investigators

Jianming Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital, Academy of Military Medical Sciences

Locations

Affiliated Hospital, Academy of Military Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Quanren Wang, Ph.D

Role: CONTACT

wangquanren@hrglobe.cn

+862161053363

Facility Contacts

Jianming Xu, PhD

Role: primary

Other Identifiers

SHR-1210-III-316

Identifier Type: -

Identifier Source: org_study_id