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

Zhejiang University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma; Lenvatinib

Treatments: Drug: Lenvatinib; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT04911959

yan2020-629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control group

Active Comparator group

Description:

patients receive transcatheter arterial chemoembolization (TACE) only.

Treatment:

Procedure: TACE

Intervention group

Experimental group

Description:

patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.

Treatment:

Drug: Lenvatinib

Procedure: TACE