Clinical Efficacy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes

Sponsor
Fujian Medical University
Study ID
NCT05610332
Phase
PHASE3
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.
  • Albumin Taxol — DRUG
    Albumin paclitaxel was administered intravenously (without pretreatment) for 30 min on the first day of each cycle
  • FLOT scheme — DRUG
    Docetaxel 50mg/m2, ivgtt, d1; Oxaliplatin 85 mg/m2, ivgtt, d1; Calcium folinate 200mg/m2, ivgtt, d1; 5-fluorouracil 2600mg/m2, 24h civ, d1, 4 cycles before and after operation, q2w

Study Details

To evaluate the clinical efficacy of albumin paclitaxel combined with carelizumab and FLOT in the neoadjuvant treatment of locally advanced gastric cancer with different immune types

Key Dates

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

Study Design

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

Arms

  • Experimental: Immune activated experimental group
    Albumin paclitaxel 260mg/m2, ivgtt, d1, d8 Carrelizumab: 200mg, ivgtt, d1, q3w
  • Active Comparator: Immune activated control group
    Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d
  • Experimental: Immune silence experimental group
    Carrelizumab: 200mg, ivgtt, d1, q3w Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d
  • Active Comparator: Immunosilent control group
    Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d

Primary Outcome Measure

Objective response rate [ Time Frame: 4 months ]

Central Contacts