Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant (NCT05103904) | Clinical Trial Compass
TerminatedPhase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
Stopped: Slow Accrual
United States3 participantsStarted 2022-04-19
Plain-language summary
This phase II trial evaluates lenvatinib for the treatment of hepatocellular carcinoma (HCC) that has come back (recurrent) after a liver transplant. HCC is a cancer of the liver and is the second leading cause of cancer-related deaths in the world. Liver transplantation is a potentially curative treatment option for HCC, however, up to 20% of patients develop recurrent disease after liver transplantation and prognosis remains poor. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Systemic treatments for HCC have not been studied in patients with recurrent HCC after liver transplantation, so there is no established therapy for these patients. This phase II trial evaluates lenvatinib for this purpose.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%)
* Patients must have recurrent histologically or cytologically confirmed hepatocellular carcinoma that has recurred after liver transplantation and not amenable for surgical resection
* Child Pugh class A
* Prior orthotropic liver transplantation for curative intent
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Life expectancy \> 12 weeks as determined by the investigator
* Hemoglobin \>= 8.0 g/dl (within 28 days of cycle 1 day 1)
* Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of cycle 1 day 1; after at least 7 days without growth factor support or transfusion)
* Platelets \>= 75,000/mcL (within 28 days of cycle 1 day 1)
* International normalized ratio (INR) =\< 2.3 (within 28 days of cycle 1 day 1)
* Total bilirubin =\< 3 times the institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 5.0 times the ULN (within 28 days of cycle 1 day 1)
* Albumin \>= 2.8 g/dL (within 28 days of cycle 1 day 1)
* Serum creatinine =\< 1.5 x ULN or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x ULN; creatinine clearance should be calculated per institutional standard (within 28 days of cycle 1 day 1)
* Urinary protein =\< 1+ on dipstick or routine urinalysi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.