Exploratory Study on Optimized Antiviral Strategy After Radical Resection of Hepatitis B-related Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This is a single-center, prospective, observational, real world study designed to evaluate the effects of peginterferon α-2b(pegabin) combined with nucleoside (acid) analogs (entecavir,ETV tenofovir,TDF tenofovir alafenamide,TAF) on patients after radical surgery for hepatitis B associated hepatocellular carcinoma by collecting data from patients at our hospital

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 1\. Age: 18-65 years old, gender is not limited; 2. Patients with hepatocellular carcinoma after radical surgical resection or radiofrequency ablation; 3. HBsAg positive; 4. Intraoperative pathology showed no residual incision margin, and imaging confirmed as complete remission (CR) within 4 weeks after operation; 5. The investigator evaluates that they can receive peginterferon and nucleoside (acid) analog therapy; 6. Sign the informed consent form and be able to comply with the requirements of the program; if the patient cannot sign the informed consent form, his/her legal guardian or agent must sign it.

Locations
Other Locations
China
Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Ledu Zhou, PhD student
zhould@csu.edu.cn
17373120367
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 360
Treatments
Nucleoside analog alone group
planning or ongoing treatment with entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and no addition or switch Patients on the pegylated interferon alfa-2b program
In the continuous treatment group of peginterferon
the subjects started oral antiviral drugs from the 2nd day after operation, and simultaneously took peginterferon alfa-2b in combination from the 4th to 8th week after operation, and stopped after 96 weeks. Continue oral antiviral drugs with peginterferon
In the pegylated interferon pulse medication group
the subjects started oral antiviral drugs from the second day after the operation, and at any time point from the 4th to the 8th week after the operation, the subjects were combined with peginterferon alfa-2b. After every 8 weeks of combined use, stop for 4 weeks (continuous oral NA is maintained during the period), and perform periodically until pegylated interferon is stopped after 96 weeks, and oral antiviral drugs are continued
Related Therapeutic Areas
Hepatitis B
Hepatitis
Liver Cancer
Sponsors
Leads: Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov

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