drugset / Trial / NCT03377400
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.
Timeline
- Start
- 2017-12-14
- Primary completion
- 2021-06-30
- Completion
- 2021-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | — | — |
| Subject | Tremelimumab | Monoclonal antibody | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | fluorouracil | Small molecule | — | — |