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

NCT04342910 | Recruiting Phase 3

• 1 other identifier: SHR-1210-III-316
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) in PD-L1 Positive Participants.

  OS was defined as the time from randomization to death due to any cause.

  Up to 27 months

Secondary Outcomes (13)

• Overall Survival (OS) in All Participants.

  Up to 27 months

• Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.

  Up to 27 months

• Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.

  Up to 27 months

• Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants

  Up to 27 months

• Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.

  Up to 27 months

Study Arms (2)

camrelizumab (SHR-1210) combined with apatinib

EXPERIMENTAL

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

Drug: camrelizumab; Drug: Apatinib Mesylate

Paclitaxel or Irinotecan

ACTIVE COMPARATOR

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.

Drug: Paclitaxel; Drug: Irinotecan

Interventions

camrelizumab DRUG

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

Also known as: SHR-1210

camrelizumab (SHR-1210) combined with apatinib

Apatinib Mesylate DRUG

250 mg qd

camrelizumab (SHR-1210) combined with apatinib

Paclitaxel DRUG

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

Paclitaxel or Irinotecan

Irinotecan DRUG

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

Paclitaxel or Irinotecan

Eligibility Criteria

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

You may qualify if:

• Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
• Confirmed metastatic or locally advanced, unresectable disease.
• Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
• Willing to provide tumor tissue for PD-L1 biomarker analysis.
• 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.
• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• Signing the informed consent forms.
• Adequate bone marrow, liver and renal function.

You may not qualify if:

• Squamous cell or undifferentiated gastric cancer.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• 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.
• Clinically significant cardiovascular and cerebrovascular diseases.
• Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
• Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
• 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.
• Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital, Academy of Military Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; apatinib; Paclitaxel; Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jianming Xu, Ph.D

  Affiliated Hospital, Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanren Wang, Ph.D

CONTACT

+862161053363; wangquanren@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: September 21, 2020
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)