A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer

Sponsor
Shanghai Minimally Invasive Surgery Center
Study ID
NCT05101616
Phase
PHASE1/PHASE2
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • camrelizumab+chemotherapy — DRUG
    camrelizumab 200mg，ivdrip，q3w； albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1\~d14，q3w. 3 cycles.
  • Chemotherapy — DRUG
    albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1\~d14，q3w. 3 cycles.

Study Details

It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.

Key Dates

Start date
Jul 1, 2022
Status verified
Mar 2024
Primary completion
Jan 1, 2025
Completion
Jan 1, 2027

Study Design

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

Arms

  • Experimental: camrelizumab+chemotherapy
    neoadjuvant treatment with camrelizumab+chemotherapy
  • Active Comparator: chemotherapy
    neoadjuvant treatment with chemotherapy

Primary Outcome Measure

major pathologic response rate [ Time Frame: one month after surgery ]

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