Effects of Antiviral Therapy on Patients With HBV-related HCC

Completed

• Conditions: Hepatitis B Virus; Hepatocellular Carcinoma; Survival
• Interventions: Other: Medication history

• Registration Number: NCT05406089
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Based on the follow-up data of patients who underwent hepatectomy for HBV-related HCC at the First Affiliated Hospital of Xi'an Jiaotong University. patients who met the enrollment criteria were screened for tumor recurrence and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Detailed Description

A retrospective study of patients who underwent hepatectomy for HBV-related HCC at the First Affiliated Hospital of Xi'an Jiaotong University from January 2016 to June 2019 was conducted. The clinical data of patients, including demographic features, perioperative laboratory values, surgical information, and pathological data, were collected from the official database for patients' data gathering, also, Based on the follow-up data of patients who met the enrollment criteria were screened for tumor recurrence and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

Age of 18-70 years; Initial hepatectomy was performed; Positive HBsAg results and negative results for antibodies to hepatitis C virus (HCVAb) and human immunodeficiency virus; The patient did not undergo antitumor treatment, such as transcatheter arterial chemoembolization, radiofrequency ablation-chemotherapy or radiotherapy, or postoperative liver transplantation; Barcelona Clinic Hepatocellular carcinoma stage 0, A, or B (a few patients with stage C were also enrolled); Negative hepatectomy margin; No other tumors.

Exclusion Criteria

Undergo antitumor treatment, such as transcatheter arterial chemoembolization, radiofrequency ablation-chemotherapy or radiotherapy, or postoperative liver transplantation; Positive results for antibodies to hepatitis C virus (HCVAb) and human immunodeficiency virus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The perioperative antiviral therapy (PAT) group	Medication history	The perioperative antiviral therapy (PAT) group was defined as individuals who received antiviral treatment perioperatively ( antiviral treatments consisted of adefovir (10 mg/day), entecavir (0.5 mg/day), and lamivudine (100 mg/day) ). Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and characteristics of this group were collected and recorded for subsequent analysis.
The short-term antiviral therapy (STAT) group	Medication history	The short-term antiviral therapy (STAT) group was defined as individuals who received HBV antiviral ( antiviral treatments consisted of adefovir (10 mg/day), entecavir (0.5 mg/day), and lamivudine (100 mg/day) )at least 24 weeks before hepatectomy (antiviral therapy still continued during perioperative period). Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and characteristics of this group were collected and recorded for subsequent analysis.

Primary Outcome Measures

Name	Time	Method
Recurrence of the hepatocellular carcinoma after hepatectomy	The time period between hepatectomy and the initial examination revealing a recurrence of hepatocellular carcinoma, or until the end of follow-up on December 31, 2020.whichever came first, assessed up to 60 months.	Recurrence of the hepatocellular carcinoma in patients who underwent hepatectomy
Post-operative survival time	Time from the end of hepatectomy to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 60 months	Postoperative survival time for patients receiving hepatectomy

Secondary Outcome Measures

Name	Time	Method
Surgery information	Intraoperative	Detailed information such as operation time