NCT07281157

Irinotecan Liposome Plus Capecitabine and Enronsubemab Combined With Short-course Radiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

The Combination of Irinotecan Liposome, Capecitabine and Enlansubemab Embedded in Short-course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: a Prospective, Single-center and Single-arm Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, single-arm study on the combination regimen of irinotecan liposome, capecitabine and enronsubemab embedded in short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy	Phase One: Induction immunotherapy Irinotecan liposome: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlangsumab: 240mg, ivgtt, d1. Repeat every two weeks for two treatment cycles Phase Two: Short-course radiotherapy Short-course radiotherapy: 5x5Gy, once a day, 5Gy each time, for 5 consecutive days. After radiotherapy, rest for 7 to 14 days before starting consolidation immunotherapy. After radiotherapy, conduct imaging evaluations of tumor remission. Phase Three: Consolidation of chemotherapy-free treatment Irinotecan liposome: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlangsumab: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles Phase Four: W\&W

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-04-30
• Completion: 2032-04-30
• First posted: 2025-12-15
• Last updated: 2025-12-30

Locations

1 site across 1 country: China