drugset / Trial / NCT04443543
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.
Timeline
- Start
- 2020-06-22
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 65 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 80 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 200 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |