drugset / Trial / NCT06647680
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer(CONTROL-01)
NaSingle-groupOpen-labelTreatment
Summary
To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | Tislelizumab | Monoclonal antibody | — | — |