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ACTIVE NOT RECRUITING
NCT04308174
PHASE2

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

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2020-05-20

Completion Date

2025-12-30

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

DRUG

Durvalumab + Gem/Cis

Neoadjuvant Durvalumab + Gemcitabine/Cisplatin

DRUG

Gem/Cis

Neoadjuvant Gemcitabine/Cisplatin

Locations (1)

Asan Medical Center

Seoul, South Korea