Cabozantinib for Liver Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byVaibhav Sahai, MBBS, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine the safety and efficacy of cabozantinib in the management of unresectable or metastatic hepatocellular carcinoma (HCC) with underlying Child-Pugh class B cirrhosis.

Research Team

Vaibhav Sahai, MBBS, MS

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults with advanced liver cancer (hepatocellular carcinoma) who have cirrhosis classified as Child-Pugh class B and have already tried one systemic therapy. They should not be eligible for curative surgery or other local treatments, must have measurable disease, good performance status (able to carry out daily activities), and adequate organ function. Pregnant women, those with recent major surgeries or active secondary cancers, uncontrolled medical conditions, or certain heart issues are excluded.

Inclusion Criteria

My condition worsened or I couldn't tolerate my first cancer treatment, and I haven't had cabozantinib.

I can undergo CT or MRI scans with contrast without issues.

Ability to understand and willingness to sign IRB-approved informed consent.

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Exclusion Criteria

I haven't needed fluid removed from my abdomen or been hospitalized for liver-related brain issues recently.

I haven't had heart failure, uncontrolled high blood pressure, or a stroke in the last 6 months.

My cancer is affecting major blood vessels, but not due to liver disease.

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Treatment Details

Interventions

Cabozantinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe study tests the safety and effectiveness of a drug called Cabozantinib in patients with hepatocellular carcinoma that cannot be removed by surgery and has spread beyond the liver. The focus is on those who also suffer from moderate liver dysfunction (Child-Pugh class B cirrhosis) after first-line treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: CabozantinibExperimental Treatment1 Intervention

Cabozantinib 20-60 mg by mouth once daily.

Cabozantinib is already approved in Canada, Japan for the following indications: