RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection
RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection
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.
we aim to compare tumor free survival and overall survival of hepatitis b virus-related
 hepatocellular carcinoma patients after curative resection with nucleotide and nucleoside
 analogues.

 Patients patients with newly diagnosed HCC according to the Milan criteria (i.e., a single
 tumor <5 cm or up to 3 nodules <3 cm) who underwent R0 resection at the Department of Liver
 Surgery and Liver Transplantation Centre of the West China Hospital of Sichuan University
 were prospectively enrolled and followed up. The diagnosis of HCC was confirmed by a
 postoperative histopathologic examination (CL, Lu). Preoperatively, all patients underwent
 chest radiography and at least 2 dynamic imaging examinations (contrast-enhanced ultrasound,
 contrast-enhanced computed tomography or magnetic resonance imaging). Hepatitis B surface
 antigen (HBsAg) and hepatitis B e antigen (HBeAg), HBV-deoxyribonucleic acid (HBV-DNA) load,
 antibodies against hepatitis C virus (anti-HCV), alpha-fetoprotein (AFP), liver function, and
 hematological parameters were serologically examined within 1 week before surgery. All
 medical records from our prospectively maintained database were reviewed retrospectively.

 Inclusion criteria for this study were as follows:

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

 2. HBsAg positiveHCV antibody negative and HIV antibody negative;

 3. HBV-DNA>200 IU/mL;

 4. BCLC stagingO 及 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. CCR≥ 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 for this study were as follows:

 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.

 2.2. Nucleotide/nucleoside analogues treatment of chronic hepatitis B

 The choice of treatment strategies for chronic hepatitis B was based on the updated
 management guidelines for chronic hepatitis B, drug resistance, and the patient's financial
 conditions.Patients who achieved a complete response with undetectable HBV-DNA and
 seroconversion to anti-HBs or anti-HBe were offered the option of continuing the antiviral
 therapy. During this time, periodic monitoring of HBV-DNA and HBeAg were continued as relapse
 remained a possibility.
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.