NCT04308174

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Neoplasms
• Gallbladder Cancer
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab + Gem/Cis	Neoadjuvant Durvalumab + Gemcitabine/Cisplatin
DRUG	Gem/Cis	Neoadjuvant Gemcitabine/Cisplatin

Timeline

• Start date: 2020-05-20
• Primary completion: 2023-06-30
• Completion: 2025-12-30
• First posted: 2020-03-13
• Last updated: 2025-01-28

Locations

1 site across 1 country: South Korea