A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2027

Conditions
Combined Hepatocellular and Cholangiocarcinoma
Interventions
DRUG

Tremelimumab

Tremelimumab is administered at 300mg intravenously once at Cycle 1.

DRUG

Durvalumab

Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+.

DRUG

Gemcitabine

Gemcitabine is administered at 1000mg/m\^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only.

DRUG

Cisplatin

Cisplatin is administered at 25mg/m\^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

collaborator

AstraZeneca

INDUSTRY

lead

Mehmet Akce

OTHER