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
NCT05699655 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2024-05-01
Summary
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
Conditions
- Immunotherapy Gastrict Cancer
Interventions
- DRUG
-
Tislelizumab
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.
- DRUG
-
apatinib
Participants will receive apatinib, 250mg, qd,every 3 weeks for 3 weeks
- DRUG
-
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
- DRUG
-
S-1
Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.
Sponsors & Collaborators
-
Fujian Cancer Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-10
- Primary Completion
- 2025-03-01
- Completion
- 2027-04-01
Countries
- China
Study Locations
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