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Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (LLTHVV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319484
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Portal Vein Tumor Thrombus Liver Transplantation Drug: lenvatinib Drug: Placebo Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Estimated Study Start Date : May 2, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Arm Intervention/treatment
Experimental: lenvatinib
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).
Drug: lenvatinib
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.
Other Name: experiment

Placebo Comparator: Placebo
The placebo pills are made identical to the investigating lenvatinib in appearance
Drug: Placebo
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.
Other Name: Control




Primary Outcome Measures :
  1. 3 years recurrence-free survival rate [ Time Frame: 3 years ]
    Tumor-free survival in 3 years


Secondary Outcome Measures :
  1. 1 year recurrence-free survival rate [ Time Frame: 1 years ]
    Tumor-free survival in 1 years

  2. 1 year overall survival rate [ Time Frame: 1 year ]
    Overall survival refers to the time from treatment to death for any reason.

  3. 3 years overall survival rate [ Time Frame: 3 years ]
    Overall survival refers to the time from treatment to death for any reason.

  4. 5 years overall survival rate [ Time Frame: 5 years ]
    Overall survival refers to the time from treatment to death for any reason.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who underwent liver transplantation were preoperatively imaging diagnosed as hepatocellular carcinoma with portal vein tumor thrombus.
  2. Male or female patients aged 18 to 75.
  3. ECOG physical condition was 0-2 points.
  4. Child-Pugh A grade of liver function.
  5. Targeted therapy is acceptable within 1-2 months after liver transplantation.
  6. Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
  7. No history of surgical resection of liver tumors and targeted drug therapy before liver transplantation.
  8. 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.
  9. For fertile female patients, the serum/urine pregnancy test should be negative within 7 days before treatment.
  10. All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
  11. The participants have the capability of oral medication.
  12. The participants must sign the consent form.

Exclusion Criteria:

  1. Hepatocellular carcinoma with invasion of hepatic vein and inferior vena cava
  2. Life expectancy is less than 3 months
  3. The recurrence and metastasis of hepatocellular carcinoma are highly suspected.
  4. Patients are with other malignant tumors simultaneously.
  5. Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
  6. Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).
  7. 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.
  8. History of HIV infection.
  9. Severe clinical active infections (> NCI-CTCAE version 3.0).
  10. Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).
  11. Patients with kidney diseases requires renal dialysis.
  12. Drug abuse, medical symptoms, mental illness or social status that may interfere with participants'participation in research or evaluation of research results.
  13. Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
  14. Other anti-angiogenesis therapies, surgery, TACE, local therapy and systemic chemotherapy were given before the treatment after liver transplantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319484


Contacts
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Contact: qiang xia, doctor +8613661889035 xiaqiang1966@126.com

Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: qiang xia, doctor RenJi Hospital
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04319484    
Other Study ID Numbers: Renji8791
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by RenJi Hospital:
Liver Transplantation
Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Lenvatinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Thrombosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action