NCT07474103

SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC

Short-Course Radiotherapy Followed by Liposomal Irinotecan, Oxaliplatin, Capecitabine, and Sintilimab as Total Neoadjuvant Therapy in High-Risk Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Exploratory Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy. All participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles. For patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program ("Watch and Wait") will be considered.

Conditions

• Rectal Cancer, Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	SCRT	25 Gy / 5 F
DRUG	Liposomal Irinotecan	50 mg/m², intravenously (IV) on Day 1 of each cycle.
DRUG	Oxaliplatin	85 mg/m², IV on Day 1 of each cycle.
DRUG	Capecitabine	800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle.
DRUG	Sintilimab	200 mg, IV on Day 1 of each cycle.

Timeline

• Start date: 2025-11-30
• Primary completion: 2028-03-31
• Completion: 2028-12-31
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China