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.

Hepatocellular Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04053972
• Other study ID #: B2019-042-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 31, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 377
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

No

Criteria:

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Drug:
• Lenvatinib
oral lenvatinib after hepatectomy

Locations

Country	Name	City	State
China	SUN YAT-SEN University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS	recurrence-free survival	From date of randomization until the date of recurrence, assessed up to 60 months
Secondary	OS	overall survival	From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary	recurrence rate	recurrence rate	1 year, 2 year, 3 year, 5 year after surgery