drugset / Trial / NCT07474103
SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC
Recruiting
49 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-11-30
- Primary completion
- 2028-03-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 800 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |