Hepatocellular CarcinomaNCT05406089
Effects of Antiviral Therapy on Patients With HBV-related HCC
An observational study of Hepatocellular Carcinoma and Hepatitis B Virus, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatitis B Virus, Survival
- What is being tested?
- Medication history
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Hepatitis B Virus, Survival
- Being tested
- Medication history
- Keywords
- Hepatitis B virus, Antiviral therapy, Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication historyOther
The study was retrospective and did not involve the application of interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medication history | |
| 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. Receives: Other: Medication history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative survival time
Postoperative survival time for patients receiving hepatectomy
Measured: 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
Recurrence of the hepatocellular carcinoma in patients who underwent hepatectomy
Measured: 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 outcomes (1)
Surgery information
Detailed information such as operation time
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jan 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Bo Wang, MD PhD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406089
- Sponsor's protocol ID
- No.XJTU1AF2021LSK-414
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term and Perioperative Antiviral Therapy on Prognosis After Hepatectomy for Hepatitis B Virus-related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05406089
- Acronym / sponsor ID
- No.XJTU1AF2021LSK-414
- Conditions
- Hepatocellular Carcinoma, Hepatitis B Virus, Survival
- Keywords
- Hepatitis B virus, Antiviral therapy, Hepatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The short-term antiviral therapy (STAT) group | – | Other: Medication historyThe 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. |
| The perioperative antiviral therapy (PAT) group | – | Other: Medication historyThe 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication historyThe study was retrospective and did not involve the application of interventions | Other | The perioperative antiviral therapy (PAT) group, The short-term antiviral therapy (STAT) group |
Primary outcome
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
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
1 secondary outcome
Surgery information
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Wang, MD PhD study chair
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Hepatitis B Virus, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.