Lenvatinib Therapy in HCC Patients After LDLT

NCT05572528 | Unknown

• 1 other identifier: PMRPG8M0041
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

New guidelines have been successfully established to distinguish the patients who were suitable for LT. This is important for long-term recurrence free and overall survival rate. We stratified patients with PET diagnosis and fetal protein response to confirm if they were the high-risk group for HCC recurrence. According to our new guidelines, high-risk tumor biology and tumor necrosis have important indicators for improving overall survival. Response to topical therapy is associated with tumor biology and post-transplant recurrence risk. In addition, 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

Liver Transplantation; Hepatocellular Carcinoma

Keywords

Liver transplantation Transplantation; Hepatocellular carcinoma; recurrence

Outcome Measures

Primary Outcomes (1)

• The recurrence rate after LDLT in high risk patients

  High risk of recurrence usually occured in two years

  follow-up to two years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Although transplant consensus recommends surveillance for recurrent HCC after LT, its early diagnosis after LT has not been associated with improved survival or reduced cancer-related mortality. This scenario is probably related to the lack of curative treatments in these patients. Moreover, recurrence occurring during the first 2 years after transplant has been associated with even worse post-recurrence survival (PRS). Early recurrences may represent an aggressive HCC with worse biological behavior after transplantation.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaoshiung Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Cheng Gang

Kaohsiung City, 83305, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

I-HSUAN CHEN, PhD

CONTACT

+88677317123; ann0401@hotmail.com

CHICHE LIN, PhD

CONTACT

+88677317123; immunologylin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

TW (1)