Tislelizumab Combined With Apatinib and 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
NCT05223088
Phase
PHASE2
Status
Completed

Conditions

  • Gastrict Cancer
  • Immunotherapy

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 3-6 weeks. 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 Mesylate — DRUG
    Participants will receive apatinib, 250mg, qd，every 3 weeks for 2-5 weeks.
  • oxaliplatin — DRUG
    Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 3-6 weeks.
  • Tegafur — DRUG
    Participants will receive Tegafur, day 1-14 of every 3 weeks for 3-6 weeks.

Study Details

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

Key Dates

Start date
Oct 31, 2021
Status verified
Mar 2025
Primary completion
Apr 30, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab combined with apatinib and oxaliplatin plus S1
    Neoadjuvant immunotherapy, PD-1, plus apatinib and oxaliplatin plus S1 will be applied to patients with Borrmann IV、large Borrmann III type and Bulky N positive advanced gastric cancer before surgery.

Primary Outcome Measure

Total/moderate tumor regression rate under pathology [ Time Frame: 4 weeks after surgery ]

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