Effects of Antiviral Therapy on Patients With HBV-related HCC

June 17, 2022 updated by: Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University

Effects of Short-term and Perioperative Antiviral Therapy on Prognosis After Hepatectomy for Hepatitis B Virus-related Hepatocellular Carcinoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age 18 or older) who underwent hepatectomy between January 1st, 2016, and June 30st, 2019, were retrospectively identified using the database for clinical data in the First Affiliated Hospital of Xi'an Jiaotong University

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The short-term antiviral therapy (STAT) group
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.
Other: Medication history
The study was retrospective and did not involve the application of interventions
The perioperative antiviral therapy (PAT) group
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.
Other: Medication history
The study was retrospective and did not involve the application of interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-operative survival time
Time Frame: 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
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
Recurrence of the hepatocellular carcinoma after hepatectomy
Time Frame: 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
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgery information
Time Frame: Intraoperative
Detailed information such as operation time
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bo Wang, MD PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • No.XJTU1AF2021LSK-414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The study was based on database from the The First Affiliated Hospital of Xi'an Jiao Tong University , researchers did not have access to patients' information nor raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xi'an Jiao Tong University.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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