Clinical Study of Camrelizumab, Apatinib Mesylate and Nab-paclitaxel Combined With Oxplatin and S-1 in the Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes

Sponsor
Fujian Medical University
Study ID
NCT05524974
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Gastric Cancer

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.
  • Oxaliplatin — DRUG
    Oxaliplatin for Injection 135mg/m2 /per day，ivgtt，in day1. Given once every 3 weeks.
  • S1 — DRUG
    S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time
  • Apatinib Mesylate — DRUG
    Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday.
  • Nab paclitaxel — DRUG
    nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8.

Study Details

To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes

Key Dates

Start date
Sep 1, 2022
Status verified
Aug 2022
Primary completion
Sep 1, 2024
Completion
Sep 1, 2027

Study Design

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

Arms

  • Experimental: Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
  • Active Comparator: Oxplatin and S-1 for Immune Genotypes
  • Experimental: Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
  • Active Comparator: Oxplatin and S-1 for Mesenchymal Genotypes
  • Experimental: Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
  • Active Comparator: Oxplatin and S-1 for Classic Genotypes
  • Active Comparator: Oxplatin and S-1 for Metabolic Genotypes

Primary Outcome Measure

Objective response rate [ Time Frame: 4 months ]

Central Contacts