drugset / Trial / NCT05713838
Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery
Phase 2
Recruiting
32 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
NaSingle-groupOpen-labelTreatment
Summary
The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial investigating whether a definite organ preservation therapy consisting of the combination of durvalumab with chemoradiation is an efficient and safe treatment option for early stage, cT1 and cT2N0, esophageal adenocarcinoma with indication for radical surgery.
Timeline
- Start
- 2023-08-28
- Primary completion
- 2025-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium folinate | Unknown | 200 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 50 mg/m2 | — |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 1600 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2600 mg/m2 | — |