Status:
UNKNOWN
Lenvatinib Combined With TACE to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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.
Detailed Description
Postoperative recurrence and metastasis of hepatocellular carcinoma(HCC）is the main problem during the treatment. Although with the development of medical science, some drugs have been found for the p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT03838796
Start Date
January 3 2019
End Date
June 1 2023
Last Update
August 2 2022
Active Locations (1)
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1
Huashan hospital
Shanghai, China, 200040