Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma

Chang Gung Medical Foundation

Status and phase: Enrolling; Early Phase 1

Conditions: High Risk of Recurrence

Treatments: Drug: Lenvatinib 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06327269

MOHW111-TDU-B-221-114009

Details and patient eligibility

About

The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A new generation of targeted therapies and adjuvant therapy after LDLT.

Active Comparator group

Description:

The proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. Lenvatinib is applied to adjuvant therapy after LDLT.

Treatment:

Drug: Lenvatinib 10 mg

prolong the recurrence-free survival to high risk of HCC after LDLT

Active Comparator group

Description:

Lenvatinib which is applied to adjuvant therapy after LDLT may prolong the recurrence-free survival

Treatment:

Drug: Lenvatinib 10 mg