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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04342910
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • camrelizumab — DRUG
    200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
  • Apatinib Mesylate — DRUG
    250 mg qd
  • Paclitaxel — DRUG
    80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Irinotecan — DRUG
    180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.

Study Details

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.

Key Dates

Start date
Sep 21, 2020
Status verified
Jan 2026
Primary completion
Apr 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Overall Survival (OS) in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]

Central Contacts

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