Actively Recruiting
Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
Led by University Health Network, Toronto · Updated on 2025-12-03
20
Participants Needed
1
Research Sites
307 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
This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients. Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors. All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.
CONDITIONS
Official Title
Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have confirmed hepatocellular carcinoma that has recurred.
- Previously had a liver transplant to treat hepatocellular carcinoma.
- Recurrent disease not suitable for surgery or local treatment.
- Must have measurable disease.
- No prior treatment with cabozantinib.
- May have had up to one prior therapy for advanced hepatocellular carcinoma with sorafenib or lenvatinib.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy greater than 3 months.
- Normal organ and marrow function.
- Adequate heart function.
- No active uncontrolled infections.
- Able to 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 during and after treatment as specified.
- Negative pregnancy test for women.
You will not qualify if you...
- Received systemic therapy or radiotherapy within 3 weeks.
- Receiving other investigational agents.
- Known brain metastases unless stable for more than 3 months.
- History of allergic reactions to cabozantinib.
- Uncontrolled or significant illnesses including cardiovascular or high-risk gastrointestinal disorders.
- Major surgery within 2 months before study entry.
- Untreated lung lesions or disease invading major blood vessels.
- Significant bleeding risk within 3 months.
- Active infections including HIV/AIDS.
- Serious non-healing wounds, ulcers, or bone fractures.
- Malabsorption syndrome.
- Uncompensated or symptomatic hypothyroidism.
- Requires dialysis.
- Pregnant women.
- Any condition that contraindicates study participation.
- Active hepatitis B or C in liver graft.
- Suspected liver cellular rejection with confirmed biopsy.
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Moderate or severe ascites.
- Use of therapeutic anticoagulants.
- History of invasive cancer unless disease-free for 2 years after curative treatment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
J
Jennifer Knox, M.D.
CONTACT
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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