Pembrolizumab + Radiotherapy for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJennifer J. Knox, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This is a phase 2 study whose purpose is to assess the efficacy of the combination of pembrolizumab and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after treatment with sorafenib.

Eligibility Criteria

Adults with advanced liver cancer (hepatocellular carcinoma) who have seen their disease progress after sorafenib treatment. They must be in good liver function (Child Pugh Class A), have no more than 10 treatable tumors within the liver, and no tumor larger than 15 cm. Participants need to provide a biopsy, not have had certain prior treatments or conditions like brain metastases or active hepatitis B and C together, and agree to use contraception if of childbearing potential.

Inclusion Criteria

Willing and able to provide written informed consent/assent for the trial

Be ≥18 years of age on day of signing informed consent

No single liver tumor >15 cm in diameter

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Exclusion Criteria

You experienced bleeding from the esophagus or stomach within the past 3 months before joining the study.

You have received a specific type of radiation therapy called radioembolization or other selective internal radiotherapy treatment to the liver in the past.

Has a histological or cytological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC

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Participant Groups

The trial is testing the effectiveness of combining pembrolizumab, an immunotherapy drug, with stereotactic body radiotherapy (SBRT) for treating advanced hepatocellular carcinoma. It's a phase 2 study where all participants receive both treatments to see how well they work together after previous sorafenib therapy has failed.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)Experimental Treatment2 Interventions

Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: