Overview

Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer

Status:
Recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
Summary
Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.
Phase:
Phase 2
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Samsung Medical Center
Treatments:
Antibodies, Monoclonal
Cisplatin
Durvalumab
Gemcitabine