A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

July 5, 2016

Primary Completion Date

February 17, 2021

Study Completion Date

December 31, 2022

Conditions
Biliary Tract NeoplasmsLiver CancerHepatocellular CarcinomaCholangiocarcinomaBile Duct Cancer
Interventions
DRUG

Durvalumab

Flat dose of 1500 mg every 4 weeks.

DRUG

Tremelimumab

Flat dose of 75 mg every 4 weeks for up to 4 doses.

PROCEDURE

Trans-arterial Catheter Chemoembolization (TACE)

TACE will be performed on Day 36 (+/-96hrs).

PROCEDURE

Radiofrequency Ablation (RFA)

RFA will be performed on Day 36 (+/-96hrs).

PROCEDURE

Cryoablation

Cryoablation will be performed on Day 36 (+/-96hrs).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02821754 - A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) | Biotech Hunter | Biotech Hunter