Lenvatinib treatment for liver cancer patients after transplantation

Lenvatinib Therapy in the Patients With High-risk Hepatocellular Carcinoma After LDLT

This study is testing if the drug lenvatinib can help prevent liver cancer from coming back in patients who have just had a liver transplant.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kaoshiung Chang Gung Memorial Hospital (Academic / other)
• Drugs / interventions: lenvatinib
• Locations: 1 site (Kaohsiung)
• Trial ID: NCT05572528 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with hepatocellular carcinoma (HCC) who are at high risk of recurrence after undergoing liver transplantation. It involves a randomized allocation of patients to receive lenvatinib therapy or supportive treatment, with the aim of assessing the efficacy and safety of lenvatinib in preventing HCC recurrence. Patients will be monitored through regular serum and imaging examinations to track tumor recurrence and side effects. The study also aims to analyze clinicopathological factors that may influence the treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are male or female patients aged 18 to 75 with high-risk hepatocellular carcinoma who have undergone liver transplantation.

Not a fit: Patients with a life expectancy of less than 3 months or those with other simultaneous malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option to reduce the risk of HCC recurrence in high-risk patients after liver transplantation.

How similar studies have performed: Other studies have explored targeted therapies in similar contexts, but this specific approach using lenvatinib post-liver transplantation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Male or female patients aged 18 to 75.
* Targeted therapy is acceptable within 1-2 months after liver transplantation.
* Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
* All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
* The definition of high-risk patients:
* The PET scan is positive before LDLT;
* Tumors beyond USCF criteria
* Poorly-differentiated tumor;
* The patients who has poor AFP response (\<15%)or AFP\>400 ng/ml after LRT after conventional LRT (RFA、PEI or TACE)

Exclusion Criteria:

* Life expectancy is less than 3 months
* Patients are with other malignant tumors simultaneously.
* Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
* Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).
* Preoperative history of severe cardiovascular disease: congestive heart failure \> NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.
* History of HIV infection.
* Severe clinical active infections (\> NCI-CTCAE version 3.0).
* Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).
* Patients with kidney diseases requires renal dialysis.
* Drug abuse, medical symptoms, mental illness or social status that may interfere with participants' participation in research or evaluation of research results.
* Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.

Where this trial is running

Kaohsiung

• Kaohsiung Cheng Gang — Kaohsiung, Taiwan (Recruiting)

Study contacts

• Study coordinator: I-HSUAN CHEN, PhD

Conditions Liver Transplantation; Hepatocellular Carcinoma; Liver transplantation Transplantation; Hepatocellular carcinoma; recurrence