NCT06451211

Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.

Conditions

• Stomach Neoplasms
• Gastric Cancer
• Linitis Plastica of Stomach

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants
DRUG	Oxaliplatin	Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants
DRUG	S-1	S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
DRUG	Capecitabine	Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants

Timeline

• Start date: 2023-05-17
• Primary completion: 2024-11-01
• Completion: 2027-11-01
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

1 site across 1 country: China