SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer
Summary
Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.
Timeline
- Start
- 2025-01-06
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iparomlimab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Tuvonralimab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |