NCT07104604

Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Toripalimab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Affiliated Cancer Hospital of Shantou University Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Irinotecan	In this study, the novel drug liposomal irinotecan was added, replacing the conventional formulation of irinotecan, and used as an intensified chemotherapy regimen (liposomal irinotecan + capecitabine) combined with immunotherapy and radiotherapy for neoadjuvant treatment of mid-lower rectal cancer.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-03-31
• Completion: 2027-06-30
• First posted: 2025-08-05
• Last updated: 2025-08-08

Locations

1 site across 1 country: China