Phase II clinical trial of cabozantinib for the treatment of recurrent hepatocellular carcinoma after liver transplantation.
Amirhossein Azhie, Robert C Grant, Michael Herman...
https://pubmed.ncbi.nlm.nih.gov/35287469Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04204850
A Phase II Trial of Cabozantinib to Treat Recurrent Hepatocellular Carcinoma After Liver Transplant
Led by University Health Network, Toronto · Updated on 2025-12-03
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug cabozantinib in patients with hepatocellular carcinoma, a type of liver cancer, who have had a liver transplant but whose cancer has returned. This phase 2 study aims to see how effective cabozantinib is in controlling the disease in these patients by blocking certain proteins that help cancer tumors grow. Participants will take cabozantinib orally at a dose of 60 mg once daily at bedtime, continuously until the drug no longer benefits them or side effects become intolerable. The study includes three parts: screening to assess safety and eligibility, the treatment period with weekly clinic visits for tests and assessments, and follow-up visits every 8 weeks after treatment ends. If side effects occur, participants will be monitored weekly for about 4 weeks, then monthly until stable. During the study, participants will undergo various tests and procedures to monitor their health and disease status, including safety assessments and research-only evaluations. The primary outcome measured is disease control rate at 4 months, with secondary outcomes including progression-free survival, overall survival, and side effects over 3 years. Participants will be followed closely throughout the study period, which continues until June 2026.
CONDITIONS
Brief Title
Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred.
- Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma.
- Not suitable for curative surgery or local treatment for recurrent disease.
- Must have measurable disease.
- No prior treatment with cabozantinib.
- May have had up to 1 line of prior therapy for advanced hepatocellular carcinoma with sorafenib or lenvatinib.
- Age 18 years or older.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy greater than 3 months.
- Normal organ and marrow function.
- Adequate cardiac function.
- No evidence of active uncontrolled infection.
- Understand and willing to sign informed consent.
- Recovered from prior toxicities to less than grade 1.
- Able to take oral medications.
- Agree to use effective contraception until at least 30 days (women) or 3 months (men) after last study drug dose with negative pregnancy test.
You will not qualify if you...
- Had systemic therapy or radiotherapy within 3 weeks.
- Receiving any other investigational agents.
- Known brain metastases unless stable for more than 3 months.
- History of allergic reactions to cabozantinib.
- Uncontrolled or recent significant illnesses including cardiovascular and gastrointestinal disorders.
- Major surgery within 2 months before randomization.
- Cavitating pulmonary lesions or untreated endobronchial disease.
- Lesion invading a major blood vessel.
- Significant bleeding risk within 3 months.
- Active infection requiring systemic treatment or known HIV/AIDS.
- Serious non-healing wounds, ulcers, or bone fractures.
- Malabsorption syndrome.
- Uncompensated or symptomatic hypothyroidism.
- Requirement for dialysis.
- Pregnant women.
- Any condition contraindicating participation due to safety or compliance concerns.
- Active hepatitis B or C in liver graft.
- Cellular rejection diagnosed by biopsy.
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Moderate or severe ascites.
- Use of anticoagulants at therapeutic doses.
- History of prior invasive malignancy without curative therapy and no recurrence for 2 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Several visits may be needed to complete the screening part of the study.
Treatment
Duration - Continuous dosing until disease progression or discontinuation
Participants take the study drug Cabozantinib as prescribed by the study doctor. During this time, participants visit the clinic about once a week for tests, procedures, and assessments for safety, eligibility, and research purposes.
Weekly visits for tests and assessments
Follow-up
Duration - Up to 3 years or until study completion
After the last dose of study drug, participants have an End of Study Drug visit about 30 days later. Following this, participants continue follow-up visits approximately every 8 weeks. If side effects occur, participants are followed weekly for about 4 weeks, then monthly until side effects resolve or stabilize.
1 visit about 30 days after last dose, then visits approximately every 8 weeks, with additional weekly and monthly visits if side effects occur
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
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Research Team
J
Jennifer Knox, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
The evolving treatment paradigm of advanced hepatocellular carcinoma: putting all the pieces back together.
Antonio D'Alessio, Antonella Cammarota, Maria Giuseppina Prete...
https://pubmed.ncbi.nlm.nih.gov/33867478