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

NCT04319484 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Renji8791
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma; Portal Vein Tumor Thrombus; Liver Transplantation

Keywords

Liver Transplantation; Hepatocellular Carcinoma; Portal Vein Tumor Thrombus; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• 3 years recurrence-free survival rate

  Tumor-free survival in 3 years

  3 years

Secondary Outcomes (4)

• 1 year recurrence-free survival rate

  1 years

• 1 year overall survival rate

  1 year

• 3 years overall survival rate

  3 years

• 5 years overall survival rate

  5 years

Study Arms (2)

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).

Drug: lenvatinib

Placebo

PLACEBO COMPARATOR

The placebo pills are made identical to the investigating lenvatinib in appearance

Drug: Placebo

Interventions

lenvatinib DRUG

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.

Also known as: experiment

lenvatinib

Placebo DRUG

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.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

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

Study Officials

• qiang xia, doctor

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

qiang xia, doctor

CONTACT

+8613661889035; xiaqiang1966@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition.

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: March 24, 2020
• Study Start: May 2, 2020
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share