NCT05563012

Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma

Single-arm Phase II Clinical Study of Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Renmin Hospital of Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.

Conditions

• Disorder in Complete Remission in Response to Treatment

Interventions

Type	Name	Description
DRUG	Sintilimal Injection	Sintilimal (200mg) will be given i.v. on day 1 of each 3-week cycle.

Timeline

• Start date: 2022-09-26
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2022-10-03
• Last updated: 2022-10-03

Locations

1 site across 1 country: China