Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC

Study Overview
=================
Brief Summary
-----------------
single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Detailed Description
-----------------
Focusing on the current status of clinical treatment of microvascular invasion (MVI) positive postoperative hepatocellular carcinoma (HCC) , single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of MVI-positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Official Title
-----------------
Study on the Safety and Effectiveness of Transcatheter Arterial Chemoembolization (TACE) Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With Microvascular Invasion (MVI) Positive Hepatocellular Carcinoma (HCC)

Conditions
-----------------
Hepatocellular Carcinoma, Lenvatinib

Intervention / Treatment
-----------------
* Drug: Lenvatinib
* Procedure: TACE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements Physical fitness score ECOG 0～2 Expected survival> 3 months No other systemic malignancies Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents Exclusion Criteria: Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation The main portal vein is completely blocked, and the formation of collateral vessels is small

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>patients receive transcatheter arterial chemoembolization (TACE) only. | Procedure: TACE<br>* TACE treatment once.<br>* Other names: Transcatheter Arterial Chemoembolization;|
| Experimental: Intervention group<br>patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day. | Drug: Lenvatinib<br>* Lenvatinib is taken orally.<br>Procedure: TACE<br>* TACE treatment once.<br>* Other names: Transcatheter Arterial Chemoembolization;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC | Up to 8 weeks | 
| Changes in tumor volume | To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC | Up to 8 weeks | 
| Recurrence-free survival (RFS) evaluation | To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease recurrence time evaluation | To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment | Through study completion, an average of 1 year | 
| Overall survival ( OS) evaluation | Overall survival time as assessed by IRC | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TACE, Hepatocellular Carcinoma, MVI, Prognosis, Lenvatinib