Immunotherapy for Liver Cancer Before Transplant

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDavendra P. Sohal

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Davendra Sohal

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.

Research Team

Davendra P. Sohal

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for adults over 18 with hepatocellular carcinoma (HCC) who haven't had prior HCC therapy, are listed for a liver transplant, and meet specific health criteria including a Child-Pugh Score of 5-7. They must have tumors within certain size limits, no extrahepatic disease or severe autoimmune disorders, and be able to follow the study protocol.

Inclusion Criteria

My organs and bone marrow are working well.

I have at least one measurable cancer lesion that has not been treated with radiation.

My body weight is over 30 kg.

See 9 more

Exclusion Criteria

Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements

I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.

I have or had an autoimmune or inflammatory condition, with some exceptions.

See 17 more

Treatment Details

Interventions

Durvalumab (Checkpoint Inhibitor)
Liver Transplant (Procedure)
Tremelimumab (Checkpoint Inhibitor)

Trial OverviewThe trial tests Durvalumab and Tremelimumab in patients with HCC awaiting liver transplants. It aims to see if immunotherapy can safely reduce tumor size and control the disease long-term to improve outcomes post-transplant.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Durvalumab + Tremelimumab + Liver TransplantExperimental Treatment3 Interventions

Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant.

Durvalumab is already approved in Japan for the following indications: