Apatinib Monotherapy Versus Apatinib Combined With Camrelizumab for Third-line Treatment of Metastatic Gastric Cancer

Sponsor
Fudan University
Study ID
NCT05095636
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-Programmed cell death-1 (PD-1) monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen.

Key Dates

Start date
Mar 17, 2021
Status verified
Oct 2021
Primary completion
Mar 31, 2023
Completion
Sep 30, 2023

Study Design

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

Arms

  • Active Comparator: apatinib monotherapy
    Apatinib，500 mg，po., qd, q2w
  • Experimental: Apatinib Combined With Camrelizumab
    Apatnib，250 mg，po., qd，q2w; Camrelizumab，200mg， ivgtt，d1, q2w

Primary Outcome Measure

PFS [ Time Frame: Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]

Central Contacts

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