drugset / Trial / NCT03377400

Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

NCT03377400 ↗

Phase 2 Unknown 40 enrolled Samsung Medical Center
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

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody — —
Subject Tremelimumab Monoclonal antibody — —
Background Cisplatin Other / unclassified — —
Background fluorouracil Small molecule — —