NCT05699655

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

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: Randomized Control, Open, Multicenter Trial-2 (TAOS-3B-Trial-2)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	oxaliplatin	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.

Timeline

• Start date: 2023-05-10
• Primary completion: 2025-03-01
• Completion: 2027-04-01
• First posted: 2023-01-26
• Last updated: 2024-05-01

Locations

1 site across 1 country: China