drugset / Trial / NCT03127007
Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer
Phase 1/2
Completed
45 enrolled
Grand Hôpital de Charleroi
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy. The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.
Timeline
- Start
- 2017-04-27
- Primary completion
- 2024-02-22
- Completion
- 2024-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Background | fluorouracil | Small molecule | 225 mg/m2 | Intravenous |