Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 23, 2022

Primary Completion Date

February 20, 2025

Study Completion Date

February 20, 2025

Conditions
Biliary Tract Cancer (CCA)Intrahepatic CholangiocarcinomaHilar CholangiocarcinomaDistal CholangiocarcinomaGall Bladder Carcinoma
Interventions
DRUG

Durvalumab

Durvalumab at a fixed dose of 1500 mg as an IV infusion over 1 hour, on day 1 together with the Tremelimumab infusion. Durvalumab only infusion to be repeated every 4 weeks for a maximum of 12 months on day 1 of each cycle.

DRUG

Tremelimumab

Tremelimumab at a fixed dose of 300 mg as an IV infusion over 1 hour on day 1 of cycle 1.

DRUG

Capecitabine

Capecitabine at 1250 mg/m² p.o. twice a day on days 1 to 14 of a 3-weekly cycle (eight cycles).

Trial Locations (1)

60488

Krankenhaus Nordwest, Frankfurt am Main

All Listed Sponsors
lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER