Lenvatinib Following Liver Transplantation in Patients With High-Risk Hepatocellular Carcinoma

NCT04168944 | Unknown Phase 2 FDA Drug

• 1 other identifier: KY2019059
• 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 high-risk recurrence of hepatocellular carcinoma patients after liver transplantation.The cases are from patients with hepatocellular carcinoma who underwent liver transplantation in the liver surgery department of Shanghai Renji Hospital. Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Tumor free survival rate

  The 1, 3, 5-year of tumor free survival rate

  5 years

Secondary Outcomes (1)

• Overall survival rate

  5 years

Other Outcomes (1)

• the side effects

  5 years

Study Arms (2)

lenvatinib group

EXPERIMENTAL

Participants are given the same anti-rejection therapy as the control group after liver transplantation. 1-2 months after liver transplantation, participants are given lenvatinib with an initial dose of 8 mgor 12 mg orally once a day. The initial dose was 8 mgor 12 mg orally once a day.

Drug: Lenvatinib; Drug: Immunosuppressive regimen

Placebo group

PLACEBO COMPARATOR

Immunosuppressive regimen consisting of calcineurin inhibitor, mycophenolate mofetil, sirolimus or ivermus

Drug: Placebo; Drug: Immunosuppressive regimen

Interventions

Lenvatinib DRUG

Patients in the lenvatinib group are given lenvatinib within 1-2 months after operation

Also known as: E7080

lenvatinib group

Placebo DRUG

Sugar pill manufactured to mimic Lenvatinib 10mg tablet

Placebo group

Immunosuppressive regimen DRUG

Immunosuppressive regimen consisting of calcineurin inhibitor, mycophenolate mofetil, sirolimus or ivermus

Placebo group; lenvatinib group

Eligibility Criteria

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

You may qualify if:

• Patients at high risk of recurrence of hepatocellular carcinoma after liver transplantation: extended Milan criteria, without vascular invasion (except for microvascular invasion suggested by pathology after operation)
• 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. ⑥Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
• ⑦No history of surgical resection of liver tumors and targeted drug therapy before liver transplantation.
• ⑧Good 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.
• ⑧For fertile female patients, the serum/urine pregnancy test should be negative within 7 days before treatment.
• ⑨All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
• ⑩The participants have the capability of oral medication.
• ⑾The participants must sign the consent form.

You may not qualify if:

• 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.
• ⑧Severe clinical active infections (\> NCI-CTCAE version 3.0).
• ⑨Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).
• ⑩Patients with kidney diseases requires renal dialysis.
• ⑾Drug abuse, medical symptoms, mental illness or social status that may interfere with participants'participation in research or evaluation of research results.
• ⑿Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
• ⒀Other 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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• 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: November 8, 2019
• First Posted: November 19, 2019
• Study Start: November 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 19, 2019

Record last verified: 2019-11