Hepatocellular Carcinoma, Lenvatinib
Conditions
Keywords
TACE, Hepatocellular Carcinoma, MVI, Prognosis, Lenvatinib
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.
Interventions
DRUGLenvatinib
Lenvatinib is taken orally.
PROCEDURETACE
TACE treatment once.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 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 | Up to 8 weeks | To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC |
| Recurrence-free survival (RFS) evaluation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease recurrence time evaluation | Through study completion, an average of 1 year | To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment |
| Overall survival ( OS) evaluation | Through study completion, an average of 1 year | Overall survival time as assessed by IRC |
Countries
China
Contacts
Primary ContactWeilin Wang
Backup ContactYuan Ding
Outcome results
None listed