Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT05699655
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Immunotherapy Gastrict Cancer

Eligibility Criteria

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

Interventions

  • Tislelizumab — DRUG
    Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
  • apatinib — DRUG
    Participants will receive apatinib, 250mg, qd，every 3 weeks for 3 weeks
  • oxaliplatin — DRUG
    Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
  • S-1 — DRUG
    Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.

Study Details

To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.

Key Dates

Start date
May 10, 2023
Status verified
May 2024
Primary completion
Mar 1, 2025
Completion
Apr 1, 2027

Study Design

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

Arms

  • Experimental: Tislelizumab combined with apatinib and oxaliplatin plus S1
  • Active Comparator: oxaliplatin plus S1

Primary Outcome Measure

Pathological complete response [ Time Frame: 4 weeks after surgery ]

Central Contacts