Actively Recruiting
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
Led by Chang Gung Memorial Hospital · Updated on 2024-04-18
40
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
M
Ministry of Health and Welfare, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Targeted therapy is acceptable within 1-2 months after liver transplantation.
- Immunosuppressive regimen includes calcineurin inhibitor, mycophenolate mofetil, and sirolimus.
- Both male and female participants must use reliable contraception during the trial and for four weeks after it ends.
- High-risk patients are defined by one or more of the following: positive PET scan before LDLT; tumors beyond UCSF criteria; poorly differentiated tumor; poor AFP response (<15%) or AFP >400 ng/ml after conventional local regional treatments (RFA, PEI, or TACE).
You will not qualify if you...
- Life expectancy is less than 3 months.
- Presence of other malignant tumors.
- Allergic reactions to lenvatinib or its inactive ingredients.
- Pregnant or breastfeeding women (female participants require a pregnancy test within 7 days before treatment).
- Severe cardiovascular disease history including congestive heart failure above NYHA grade 2, recent myocardial infarction within 6 months, severe arrhythmia needing treatment, or uncontrolled hypertension.
- History of HIV infection.
- Severe active infections (above NCI-CTCAE version 3.0).
- Epilepsy requiring medication such as steroids or antiepileptic drugs.
- Kidney disease requiring dialysis.
- Drug abuse, mental illness, or social circumstances that might interfere with study participation or result evaluation.
- Inability to swallow oral drugs due to severe gastrointestinal obstruction or need for gastric tube feeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Surgery
Kaohsiung City, Taiwan, 833
Actively Recruiting
Research Team
C
Chih-Che Lin, Ph.D
CONTACT
I
I-Hsuan Chen, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here