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

Cholangiocarcinoma Clinical Trial

Official title:
Randomized Phase 2 Study of Preoperative Gemcitabine Plus Cisplatin With or Without Durvalumab (MEDI4736) Followed by Postoperative Durvalumab (MEDI4736) in Patients With Localized Biliary Tract Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04308174
Study type Interventional
Source Asan Medical Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 20, 2020
Completion date December 30, 2024
View Details
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