Status:
COMPLETED
TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Sorafenib
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurre...
Detailed Description
The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive...
Eligibility Criteria
Inclusion
- Age: 18-75 years;
- Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
- Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion \>3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
- Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
- Eastern Cooperative Oncology Group scoring 0-1;
- Child-Pugh A class;
- At least 3 months of life expectancy;
- Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10\^9/L, platelet ≥ 60 x10\^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT \< 5×ULN, AST \< 5×ULN, alkaline phosphatase \< 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine\<1.5×ULN.
Exclusion
- Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden\>50%;
- Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
- Have contraindications for TACE;
- Have metastasis in central nervous system;
- Allergic to intravenous contrast agents;
- Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
- Infection of HIV, known syphilis requiring treatment;
- Have a known history of prior invasive malignancies within 5 years before enrolment;
- Patients with allotransplantation;
- Severe dysfunction involving heart, kidney or other organs;
- Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
- Patients with mental disorders which may impact informed consent;
- Unable to orally take drugs;
- Participating other clinical drug trials 12 months before enrolment.
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04103398
Start Date
October 2 2019
End Date
December 31 2023
Last Update
February 28 2024
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080