NCT06327269RecruitingEarly phase 1
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 18 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 1 Apr 2021
- Primary completion date
- Dec 2024
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06327269
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 40
- From 1 Apr 2021 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
Other illness
- Patients are with other malignant tumors simultaneously.
- 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.
Other
- Life expectancy is less than 3 months
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Surgery Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.