Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 10, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Hepatocellular CancerHepatocellular CarcinomaMetastatic Hepatocellular Carcinoma
Interventions
DRUG

durvalumab

1,150 mg flat dose every 21 days, starting on day 1 of cycle 1

DRUG

Doxorubicin-Eluting Beads

used for TACE (only in patients with HCC BCLC stage B)

PROCEDURE

TACE

TACE with Doxorubicin-Eluting Beads (only in patients with HCC BCLC stage B) on Cycle 2. More TACE can be done if clinically necessary.

DRUG

bevacizumab

7.5 mg/kg dose every 21 days, starting on day 1 of cycle 2

DRUG

Tremelimumab

300, 150 or 75 mg once on day 1 of cycle 1

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH