The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

NCT04053972 | Unknown Phase 3 DMC

• 1 other identifier: B2019-042-01
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

Brief Summary

To compare The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• RFS

  recurrence-free survival

  From date of randomization until the date of recurrence, assessed up to 60 months

Secondary Outcomes (2)

• OS

  From date of randomization until the date of death from any cause, assessed up to 60 months

• recurrence rate

  1 year, 2 year, 3 year, 5 year after surgery

Study Arms (2)

treatment group

EXPERIMENTAL

adjuvant lenvatinib

Drug: Lenvatinib

control group

NO INTERVENTION

no intervention

Interventions

Lenvatinib DRUG

oral lenvatinib after hepatectomy

treatment 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:

• older than 18 years old and younger than 75 years; ECOG PS\<3; proven hepatocellular carcinoma with MVI according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma.

You may not qualify if:

• cannot tolerate lenvatinib; CNS or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorreage or cardiac/brain vascular events within 30 days; pregnancy;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 13, 2019
• Study Start: January 31, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CN (1)