Using cabozantinib to treat liver cancer that has returned after transplant
A Phase II Trial of Cabozantinib in the Treatment of Recurrent Hepatocellular Carcinoma Post Liver Transplant
This study is testing if cabozantinib can help people with liver cancer that has come back after a liver transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | cabozantinib, lenvatinib |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04204850 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed recurrent hepatocellular carcinoma who have previously had a liver transplant.
Not a fit: Patients who have not had a liver transplant or those with active uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for managing recurrent liver cancer in patients who have undergone a transplant.
How similar studies have performed: Other studies have shown promise with cabozantinib in treating various cancers, but this specific application in post-transplant liver cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.