Using cabozantinib to treat liver cancer that has returned after transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study evaluates the effectiveness of cabozantinib in patients with recurrent hepatocellular carcinoma who have previously undergone a liver transplant. Participants will receive cabozantinib until they no longer benefit from the treatment or experience intolerable side effects. The study includes a screening phase for safety and eligibility, followed by a treatment phase with regular clinic visits for monitoring. After treatment, participants will have follow-up visits to assess their health and any side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred.
* Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC).
* Not amenable to curative surgery or local treatment for recurrent disease.
* Must have measurable disease.
* No prior treatment with cabozantinib. May be systemic therapy naïve or have received up to 1 line of prior therapy for advanced HCC with sorafenib or lenvatinib.
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 01.
* Life expectancy of \>3 months.
* Normal organ and marrow function.
* Adequate cardiac function.
* No evidence of active uncontrolled infection.
* Understand and willing to sign written informed consent document.
* Recovered from prior toxicities to \< grade 1.
* Able to take oral medications.
* Agree to use effective contraceptive methods until at least 30 days (for women) and 3 months (for men) after the last administration of study medication. Serum pregnancy test should be negative.

Exclusion Criteria:

* Had systemic therapy or radiotherapy \<3 weeks.
* Receiving any other investigational agents.
* With known brain metastases unless stable for \>3 months.
* History of allergic reactions attributed to cabozantinib.
* Has uncontrolled, significant intercurrent or recent illness:
* Cardiovascular disorders
* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
* Major surgery within 2 months before randomization
* Cavitating pulmonary lesion(s) or endobronchial disease (untreated)
* Lesion invading a major blood vessel
* Clinically significant bleeding risk \<3 months
* Other clinically significant disorders:
* Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness
* Serious non-healing wound/ulcer/bone fracture
* Malabsorption syndrome
* Uncompensated/symptomatic hypothyroidism
* Requirement for hemodialysis or peritoneal dialysis
* Pregnant women.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
* Active hepatitis B or C in liver graft
* Patients with a grade \>= 2 elevated liver enzymes who are suspected of cellular rejection will undergo biopsy. Patients diagnosed with cellular rejection in the biopsy sample using the Banff schema are ineligible.
* Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
* Moderate or severe ascites
* Concomitant use of anticoagulants at therapeutic doses
* Has a known history of prior invasive malignancy except if patient has undergone curative-intent therapy with no evidence of disease recurrence for 2 years prior to study entry.

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Jennifer Knox, M.D. — Princess Margaret Cancer Centre
• Study coordinator: Jennifer Knox, M.D.
• Email: jennifer.knox@uhn.ca
• Phone: 416-946-2399

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Identifying Prognostic Factors for Liver Disease and Transplant Needs

  This study is trying to find out which factors can help predict if people with certain liver diseases will need a transplant or develop liver cancer.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bologna · NCT06813508

• Using machine perfusion to improve liver transplant outcomes for patients with liver cancer

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  Recruiting Azienda Ospedaliero-Universitaria di Modena · Modena, MO · NCT06236568

• Combining cabozantinib with ipilimumab/nivolumab and TACE for liver cancer treatment

  This study is testing if combining cabozantinib with two immune therapies and a specific type of chemo can help people with liver cancer who can’t have surgery feel better.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT04472767

• Combining cabozantinib and durvalumab for advanced gastrointestinal cancers

  This study is testing a new combination of two cancer drugs, cabozantinib and durvalumab, to see if they can help people with advanced gastrointestinal cancers feel better and improve their outcomes.

  Recruiting Phase 1/2 University of Pittsburgh · Westwood, Kansas and 1 other locations · NCT03539822

• InstaSure Non-Invasive Finger-Press Test for HCC

  This study tests a non-invasive finger-skin test to help identify hepatocellular carcinoma in adults.

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• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

  This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.

  Recruiting at 2 sites Phase 3 BeOne Medicines · South Brisbane, Queensland and 1 other locations · NCT07836530

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.