Clinical Trial

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

Recruiting
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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.
Trial Details
NCT Number NCT07474103
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Rectal Cancer, Adenocarcinoma
Enrollment 49 participants
Start Date 2025-11-30
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-16