Hepatocellular CarcinomaPhase 2/3LLTHVVNCT04319484
Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
A Phase 2/3 study testing lenvatinib in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, run by RenJi Hospital.
Trial summary
The aim of this study is to observe the efficacy and safety of lenvatinib in preventing recurrence of hepatocellular carcinoma patients with portal vein tumor thrombus after liver transplantation. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Liver Transplantation
- What is being tested?
- lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2020to 1 Dec 2025
- Phase
- Phase 2/3
- 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 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who underwent liver transplantation were preoperatively imaging diagnosed as hepatocellular carcinoma with portal vein tumor thrombus.
- Male or female patients aged 18 to 75.
- ECOG physical condition was 0-2 points.
- Child-Pugh A grade of liver function.
- Targeted therapy is acceptable within 1-2 months after liver transplantation.
- Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
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- No history of surgical resection of liver tumors and targeted drug therapy before liver transplantation.
- Good liver, kidney and bone marrow function: serum albumin > 28g/L, total bilirubin ≤ 3 mg/dL (51.3 umol/l), ALT and AST ≤ 5 times the upper limit of normal range; serum creatinine ≤ 1.5 times the upper limit of normal range; hemoglobin > 90 g/L, neutrophil count (ANC) > 1.5 * 10 ^ 9/L, platelet count > 60 * 10 ^ 9/L; PT-INR < 2.3, or PT within 6 seconds over normal upper limit.
- For fertile female patients, the serum/urine pregnancy test should be negative within 7 days before treatment.
- All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
- The participants have the capability of oral medication.
- The participants must sign the consent form.
Who cannot join
- Hepatocellular carcinoma with invasion of hepatic vein and inferior vena cava
- Life expectancy is less than 3 months
- The recurrence and metastasis of hepatocellular carcinoma are highly suspected.
- 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).
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- 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.
- Other anti-angiogenesis therapies, surgery, TACE, local therapy and systemic chemotherapy were given before the treatment after liver transplantation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study of Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
The aim of this study is to observe the efficacy and safety of lenvatinib in preventing recurrence of hepatocellular carcinoma patients with portal vein tumor thrombus after liver transplantation.
Read the detailed description
The research is an open, randomized, single-center study. Patients of hepatocellular carcinoma with portal vein cancer thrombus who underwent liver transplantation are included according to the criteria of admission. After operation, the regimen of calcineurin inhibitors, mycophenolate mofetil, sirolimus or everolimus with glucocorticoids removed at an early stage are used. Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition. 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). 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 hepatocellular carcinoma with portal vein tumor thrombus 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 in the control group can add lenvatinib, and patients in the lenvatinib group can decide whether to continue using it according to the patients' condition).
- Being tested
- lenvatinib, Placebo
- Keywords
- Liver Transplantation, Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenvatinibDrug
Also called experiment
1-2 months after liver transplantation, participants are given lenvatinib with an initial dose of 8 mg (body weight < 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight < 60 kg) or 12 mg orally once a day.
PlaceboDrug
Also called Control
1-2 months after liver transplantation, participants are given Placebo with an initial dose of 8 mg (body weight < 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight < 60 kg) or 12 mg orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| lenvatinib | Experimental | 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). Receives: Drug: lenvatinib |
| Placebo | Placebo comparator | The placebo pills are made identical to the investigating lenvatinib in appearance Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years recurrence-free survival rate
Tumor-free survival in 3 years
Measured: 3 years
Secondary outcomes (4)
1 year recurrence-free survival rate
Tumor-free survival in 1 years
Measured: 1 years
1 year overall survival rate
Overall survival refers to the time from treatment to death for any reason.
Measured: 1 year
3 years overall survival rate
Overall survival refers to the time from treatment to death for any reason.
Measured: 3 years
5 years overall survival rate
Overall survival refers to the time from treatment to death for any reason.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start2 May 2020 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- qiang xia, doctor, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319484
- Sponsor's protocol ID
- Renji8791
- Acronym
- LLTHVV
- Status last verified
- Mar 2020
- First submitted
- 19 Jan 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT04319484
- Acronym / sponsor ID
- LLTHVV / Renji8791
- Keywords
- Liver Transplantation, Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Lenvatinib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 2 May 2020 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Mar 2020 (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.
The aim of this study is to observe the efficacy and safety of lenvatinib in preventing recurrence of hepatocellular carcinoma patients with portal vein tumor thrombus after liver transplantation.
Detailed description
The research is an open, randomized, single-center study. Patients of hepatocellular carcinoma with portal vein cancer thrombus who underwent liver transplantation are included according to the criteria of admission. After operation, the regimen of calcineurin inhibitors, mycophenolate mofetil, sirolimus or everolimus with glucocorticoids removed at an early stage are used. Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition. 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). 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 hepatocellular carcinoma with portal vein tumor thrombus 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 in the control group can add lenvatinib, and patients in the lenvatinib group can decide whether to continue using it according to the patients' condition).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition.
| Arm | Type | Receives |
|---|---|---|
| lenvatinib | Experimental | Drug: lenvatinibPatients 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). |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo pills are made identical to the investigating lenvatinib in appearance |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who underwent liver transplantation were preoperatively imaging diagnosed as hepatocellular carcinoma with portal vein tumor thrombus.
- Male or female patients aged 18 to 75.
- ECOG physical condition was 0-2 points.
- Child-Pugh A grade of liver function.
- Targeted therapy is acceptable within 1-2 months after liver transplantation.
Key exclusion criteria (14 listed)
- Hepatocellular carcinoma with invasion of hepatic vein and inferior vena cava
- Life expectancy is less than 3 months
- The recurrence and metastasis of hepatocellular carcinoma are highly suspected.
- Patients are with other malignant tumors simultaneously.
- Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenvatinibAlso: experiment1-2 months after liver transplantation, participants are given lenvatinib with an initial dose of 8 mg (body weight < 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight < 60 kg) or 12 mg orally once a day. | Drug | lenvatinib |
| PlaceboAlso: Control1-2 months after liver transplantation, participants are given Placebo with an initial dose of 8 mg (body weight < 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight < 60 kg) or 12 mg orally once a day. | Drug | Placebo |
Primary outcome
3 years recurrence-free survival rate
Time frame: 3 years
Tumor-free survival in 3 years
4 secondary outcomes
1 year recurrence-free survival rate
Time frame: 1 years
1 year overall survival rate
Time frame: 1 year
3 years overall survival rate
Time frame: 3 years
5 years overall survival rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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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.
qiang xia, doctor study chair
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lenvatinib in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, run by RenJi Hospital.
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 12 inclusion and 14 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 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 qiang xia, doctor (+8613661889035, xiaqiang1966@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 years recurrence-free survival rate (time frame: 3 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 24 Mar 2020.