drugset / Trial / NCT06718543
Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.
Timeline
- Start
- 2025-02-10
- Primary completion
- 2026-10-31
- Completion
- 2027-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 850 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Ivonescimab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |