Liver TransplantationNCT05572528
Lenvatinib Therapy in HCC Patients After LDLT
An observational study of Liver Transplantation and Hepatocellular Carcinoma, run by Kaoshiung Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation, Hepatocellular Carcinoma
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Cheng Gang
Kaohsiung City, 83305
CHICHE LIN, PhD, +88677317123 ext. 3022, immunologylin@gmail.com
I-HSUAN CHEN, PhD, +88677317123 ext. 8582, ann0401@cgmh.org.tw
About this study
Official title: Lenvatinib Therapy in the Patients With High-risk Hepatocellular Carcinoma After LDLT
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.
Read the detailed description
The research is an open, randomized, single-center study. Patients with high-risk recurrence of hepatocellular carcinoma who underwent liver transplantation are included according to the criteria of admission. Patients enrolled in the study were randomly allocated in the lenvatinib group (30 patients) after stable condition. We will use retrospective data to be as the control group. Patients in the control group are given supportive treatment and regular follow-up. Patients in the lenvatinib group are given lenvatinib within 1-2 months after operation (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day) for two years. The baseline data of patients are collected before allocation. Serum and imaging examination are checked regularly every month to monitor the recurrence of hepatocellular carcinoma and the side effects of lenvatinib. The efficacy and safety of lenvatinib in patients of high-risk hepatocellular carcinoma are observed, and the clinicopathological factors affecting the efficacy of lenvatinib are analyzed. When side effects of lenvatinib occur, the dosage can be reduced according to the patients' condition until discontinuation. When tumor recurrence occurs, a multidisciplinary team will draw up specific treatment plans according to the patients' condition, including surgical resection, interventional therapy, radiofrequency therapy, radiotherapy and targeted therapy.
Patients Criteria
Inclusion Criteria:
Enroll criteria
- 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 (under 15%)or AFPabove 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 above 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.
- Conditions
- Liver Transplantation, Hepatocellular Carcinoma
- Keywords
- Liver transplantation Transplantation, Hepatocellular carcinoma, recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate after LDLT in high risk patients
High risk of recurrence usually occured in two years
Measured: follow-up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kaoshiung Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572528
- Sponsor's protocol ID
- PMRPG8M0041
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenvatinib Therapy in the Patients With High-risk Hepatocellular Carcinoma After LDLT
- ClinicalTrials.gov ID
- NCT05572528
- Acronym / sponsor ID
- PMRPG8M0041
- Conditions
- Liver Transplantation, Hepatocellular Carcinoma
- Keywords
- Liver transplantation Transplantation, Hepatocellular carcinoma, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaoshiung Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research is an open, randomized, single-center study. Patients with high-risk recurrence of hepatocellular carcinoma who underwent liver transplantation are included according to the criteria of admission. Patients enrolled in the study were randomly allocated in the lenvatinib group (30 patients) after stable condition. We will use retrospective data to be as the control group. Patients in the control group are given supportive treatment and regular follow-up. Patients in the lenvatinib group are given lenvatinib within 1-2 months after operation (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day) for two years. The baseline data of patients are collected before allocation. Serum and imaging examination are checked regularly every month to monitor the recurrence of hepatocellular carcinoma and the side effects of lenvatinib. The efficacy and safety of lenvatinib in patients of high-risk hepatocellular carcinoma are observed, and the clinicopathological factors affecting the efficacy of lenvatinib are analyzed. When side effects of lenvatinib occur, the dosage can be reduced according to the patients' condition until discontinuation. When tumor recurrence occurs, a multidisciplinary team will draw up specific treatment plans according to the patients' condition, including surgical resection, interventional therapy, radiofrequency therapy, radiotherapy and targeted therapy.
Patients Criteria
Inclusion Criteria:
Enroll criteria
- 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 (under 15%)or AFPabove 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 above 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The recurrence rate after LDLT in high risk patients
Time frame: follow-up to two years
High risk of recurrence usually occured in two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Hepatocellular Carcinoma, run by Kaoshiung Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-HSUAN CHEN, PhD (+88677317123 ext. 8582, ann0401@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate after LDLT in high risk patients (time frame: follow-up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.