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)
Overview
- Phase
- Phase 1
- Intervention
- Lenvatinib
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Recurrence-free survival (RFS) evaluation
- Last Updated
- 3 years ago
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.
Investigators
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
Arms & Interventions
Intervention group
patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
Intervention: Lenvatinib
control group
patients receive transcatheter arterial chemoembolization (TACE) only.
Intervention: TACE
Intervention group
patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
Intervention: TACE
Outcomes
Primary Outcomes
Recurrence-free survival (RFS) evaluation
Time Frame: Through study completion, an average of 1 year
To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Incidence of adverse events
Time Frame: Up to 8 weeks
To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Changes in tumor volume
Time Frame: Up to 8 weeks
To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Secondary Outcomes
- Overall survival ( OS) evaluation(Through study completion, an average of 1 year)
- Disease recurrence time evaluation(Through study completion, an average of 1 year)