Status:
UNKNOWN
The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To compare The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.
Eligibility Criteria
Inclusion
- No
- Criteria:
- older than 18 years old and younger than 75 years; ECOG PS\<3; proven hepatocellular carcinoma with MVI according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma.
Exclusion
- cannot tolerate lenvatinib; CNS or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorreage or cardiac/brain vascular events within 30 days; pregnancy;
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT04053972
Start Date
January 31 2018
End Date
December 31 2022
Last Update
August 13 2019
Active Locations (1)
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1
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, China, 510060