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Checkpoint Inhibitor

Immunotherapy for Liver Cancer Before Transplant

Phase 2

Recruiting

Led By Davendra Sohal, MD

Research Sponsored by Davendra Sohal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization

Body weight >30 kg

Must not have

History of leptomeningeal carcinomatosis

Active infection including tuberculosis, hepatitis B, hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up survival follow up will continue for 5 years after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial shows that immunotherapy can help people with liver cancer by reducing the amount of cancer before a liver transplant.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include immune-related reactions that may affect organs, infusion-related symptoms like fever or chills, fatigue, possible digestive issues such as diarrhea or colitis, skin conditions like rash or itching, hormonal imbalances affecting thyroid function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My body weight is over 30 kg.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My liver tumor fits the specific size and number criteria for transplant.

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I have never received treatment for liver cancer.

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I have liver cancer diagnosed by a biopsy or specific scans.

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I am listed for a liver transplant by the transplant team.

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My liver function score is between 5 and 7.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer spread to the lining of my brain and spinal cord.

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I do not have active infections like TB or hepatitis.

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My cancer has spread outside of the liver.

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I do not have any serious ongoing illnesses that would affect my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ survival follow up will continue for 5 years after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~survival follow up will continue for 5 years after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and survival follow up will continue for 5 years after end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cellular rejection rates

Secondary study objectives

Adverse events during treatment, and graft loss and mortality rates

Pathologic responses via explanted liver assessment

Radiologic responses via RECIST 1.1 and/or mRECIST

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liver Transplant

2017

N/A

~60

Durvalumab

2017

Completed Phase 2

~3750