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New treatment option for Hepatocellular Carcinoma
Official title Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
ClinicalTrials.gov ID: NCT04204850
What this study is testing
What is Cabozantinib?
Cabozantinib is an investigational medicine, given as an once-weekly, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as CABOMETYX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.