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Trial Title:
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
NCT ID:
NCT06327269
Condition:
High Risk of Recurrence
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Lenvatinib
Conditions: Keywords:
living donor liver transplantation (LDLT)
hepatocellular carcinoma (HCC)
PET
proton
yttrium 90
Lenvatinib
adjuvant treatment
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib 10 mg
Description:
Lenvatinib would be used on patients with advanced liver cancer after Liver
transplantation as an adjuvant treatment.
Arm group label:
A new generation of targeted therapies and adjuvant therapy after LDLT.
Arm group label:
prolong the recurrence-free survival to high risk of HCC after LDLT
Other name:
Lenvima®
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Surgery
Address:
City:
Kaohsiung
Zip:
833
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chih-Che Lin, Ph.D
Phone:
+88677317123
Phone ext:
8880
Email:
chihchelin@cgmh.org.tw
Contact backup:
Last name:
I-Hsuan Chen, Ph.D
Phone:
+88677317123
Phone ext:
8582
Email:
ann0401@cgmh.org.tw
Start date:
April 1, 2021
Completion date:
December 2026
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Ministry of Health and Welfare, Taiwan
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327269
