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

NCT ID: NCT06327269

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

High Risk of Recurrence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Lenvatinib 10 mg

Intervention Type: DRUG

Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.

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

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

Group Type: ACTIVE_COMPARATOR

Lenvatinib 10 mg

Intervention Type: DRUG

Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.

Interventions

Lenvatinib 10 mg

Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.

Intervention Type: DRUG

Other Intervention Names

Lenvima®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Surgery

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-Che Lin, Ph.D

Role: CONTACT

chihchelin@cgmh.org.tw

+88677317123 ext. 8880

I-Hsuan Chen, Ph.D

Role: CONTACT

ann0401@cgmh.org.tw

+88677317123 ext. 8582

Facility Contacts

Chih-Che Lin, Ph.D

Role: primary

chihchelin@cgmh.org.tw

+88677317123 ext. 8880

I-Hsuan Chen, Ph.D

Role: backup

ann0401@cgmh.org.tw

+88677317123 ext. 8582

References

Han B, Ding H, Zhao S, Zhang Y, Wang J, Zhang Y, Gu J. Potential Role of Adjuvant Lenvatinib in Improving Disease-Free Survival for Patients With High-Risk Hepatitis B Virus-Related Hepatocellular Carcinoma Following Liver Transplantation: A Retrospective, Case Control Study. Front Oncol. 2020 Dec 7;10:562103. doi: 10.3389/fonc.2020.562103. eCollection 2020.

Reference Type: RESULT

PMID: 33365268 (View on PubMed)

Other Identifiers

MOHW111-TDU-B-221-114009

Identifier Type: -

Identifier Source: org_study_id