Lenvatinib Combined With TACE to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to observe the effect of Lenvatinib Combined With TACE in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

• The characteristics of the treatment history:

No lenvatinib treatment history, no sorafenib allergies.

• The characteristics of the tumor:

The pathological results is hepatocellular carcinoma.

Meet any of the following articles:

Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number≥3,Tumor size≥8cm,Tumor margin is not clear and no complete capsule.

With the embolus in Portal vein, hepatic vein or bile duct. Preoperative rupture or invasion the adjacent organs.

• The characteristics of the patients:

The patient age was between 18-75. The American Society of Anesthesiologists(ASA）score was I-III. The Child-pugh score was A. Total bilirubin≤3.0 mg/dL, albumin≥28 g/L, AST, ALT, ALP≤5 times the upper limit of normal value.

Routine blood test: the neutrophil≥1.5×10^9/L, Hb≥8.5g/L，PLT≥75×10^9/L. The INR≤2.3. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points

Exclusion Criteria:

• R1/2 or palliative rescted tumor

• Pregnant or lactating women.

• Patients with other malignant tumor.

• Patients with mental illness.

• Patients participated in other clinical trials in last three months.

• Residual lesions showed by Postoperative digital subtraction angiography(DSA).

• Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment