Status:
ACTIVE_NOT_RECRUITING
RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection
Lead Sponsor:
West China Hospital
Conditions:
HCC
HBV Coinfection
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief Summary
In Asia, hepatocellular carcinoma (HCC) commonly occurred in the underlying hepatitis B virus (HBV)-related liver disease.Curative therapies could improve the prognosis of HCC patients. However, tumor...
Detailed Description
The study was designed to compare the efficacy of ETV and TDF for patients with HBV-related HCC patients undergoing curative liver resection. Eligible patients were randomly assigned in a 1:1 ratio vi...
Eligibility Criteria
Inclusion
- older than 18 years and less than 69 years old;
- HBsAg positive HCV antibody negative and HIV antibody negative;
- HBV-DNA\>200 IU/mL;
- BCLC（Barcelona Clinic Liver Cancer） staging O and A stage;
- Platelet100×10\^9/L;
- Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two large branches, no extrahepatic metastasis;
- Creatinine clearance rate≥ 70 mL/min;
- Antiviral treatment was not performed before surgery or antiviral treatment was accepted in a short term (\<3 months);
- No treatment was performed before the operation. The results of postoperatively histopathological biopsy were HCC;
- The patients agree to participate in the clinical trial.
Exclusion
- The image found extrahepatic lymph nodes or visceral metastasis, the existence of large vascular invasion, the existence of bile duct embolus in the first operation;
- The patient combined with a malignant tumor of other organs or had a history of other malignant tumors in other organs;
- Liver function decompensation, such as: upper gastrointestinal bleeding, refractory ascites, coagulation dysfunction and so on;
- contraindications to surgery;
- Patients with poor compliance and not adhered to the follow-ups;
- Patients refused to participate in the clinical trial.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04032860
Start Date
July 1 2017
End Date
July 1 2026
Last Update
May 25 2022
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000