NCT06482788

Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.

Detailed description

The study will evaluate the efficacy and safety of the immunotherapy (Adebrelimab) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma. Potential study participants will be assessed for eligibility during a 28-day screening period that includes central verification of clinical stage and eligibility. Eligible patients will be receive perioperative treatment with adebrelimab with XELOX. Location of the primary (GEJ type I vs. GEJ type II/III vs. stomach), and PD-L1-status (CPS≥5 vs. CPS\<5). Microsatellite Instability (MSI-H vs MSI-L) will be will be given special attention.

Conditions

• Esophagogastric Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab (anti-PD-L1) + XELOX	Adebrelimab: 1200mg, i.v., each infusion lasts 30-60 minutes and is administered on the first day of each cycle (3 weeks). Capecitabine: 1000mg/m2 , bid, orally, from day 1 to day 14 of each cycle (3 weeks). Oxaliplatin: 130mg/m2, i.v., each infusion is administered on the first day of each cycle (3 weeks).

Timeline

• Start date: 2024-05-22
• Primary completion: 2025-05-31
• Completion: 2027-05-31
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

1 site across 1 country: China