Overview

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

Status:
Active, not recruiting
Trial end date:
2023-04-07
Target enrollment:
0
Participant gender:
All
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 recurrence after curative therapy remains high with a 5-year recurrence rate >70%.The risk for HCC development is increased for patient with HBV infection，but there was no consensus about which kind of oral antiviral treatment was the best option in the prevention of HBV related HCC recurrence after curative treatment.Therefore, we conducted this study to investigate the different effects of nucleotides(TDF) and nucleosides(ETV) on the prognosis of HBV-related HCC after curative resection.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
West China Hospital
Treatments:
Antiviral Agents
Entecavir
Tenofovir
Criteria
Inclusion Criteria:

1. older than 18 years and less than 69 years old;

2. HBsAg positive HCV antibody negative and HIV antibody negative;

3. HBV-DNA>200 IU/mL;

4. BCLC（Barcelona Clinic Liver Cancer） staging O and A stage;

5. Platelet100×10^9/L;

6. Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two
large branches, no extrahepatic metastasis;

7. Creatinine clearance rate≥ 70 mL/min;

8. Antiviral treatment was not performed before surgery or antiviral treatment was
accepted in a short term (<3 months);

9. No treatment was performed before the operation. The results of postoperatively
histopathological biopsy were HCC;

10. The patients agree to participate in the clinical trial.

Exclusion Criteria:

1. 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;

2. The patient combined with a malignant tumor of other organs or had a history of other
malignant tumors in other organs;

3. Liver function decompensation, such as: upper gastrointestinal bleeding, refractory
ascites, coagulation dysfunction and so on;

4. contraindications to surgery;

5. Patients with poor compliance and not adhered to the follow-ups;

6. Patients refused to participate in the clinical trial.