NCT06765616

Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer

Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer: a Multicenter, Single Arm Prospective Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Feng Tian · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 \* 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 \* 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan. TME surgery will be performed 2-3 weeks after the last dose of neoadjuvant therapy. If the surgery cannot be performed within the time window specified in the protocol (such as delayed adverse reactions, etc.), the researcher will consider the actual clinical situation of the subjects comprehensively.

Conditions

• Rectal Cancer
• Advanced Stage Colorectal Cancer
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Adebrelimab Injection combined with radiotherapy and chemotherapy	Radiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle. Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14): Oxaliplatin 130 mg/m2 iv d1 Capecitabine 1000 mg/m2 po bid d1\~14 Repeat every 3 weeks for 6 cycles After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: China