Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer
Summary
Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Several studies (including the UNION, STELLAR, TORCH, and SPRING-01 trials, etc) have demonstrated that the neoadjuvant strategy of short-course radiotherapy followed by chemotherapy combined with immunotherapy can improve pCR rate in patients with pMMR/MSS LARC, and might also provide higher organ preservation rates and long-term survival benefits. The study aims to explore the efficacy and safety of a TNT regimen comprising short-course radiotherapy combined with chemotherapy, cetuximab N01 (for patients with wild-type RAS/BRAF) or bevacizumab (for patients with mutant RAS/BRAF), and sintilimab in patients with high-risk LARC.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |