NCT05466565

Antiviral Therapy for Patients With Liver Cancer After Surgery

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 360 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

In this study, patients eligible for conventional oral antiviral therapy (ETV, TDF and TAF) after radical surgery for HBV-HCC will be screened, and the subjects who fully meet the inclusion and exclusion criteria will be included in the study after signing the informed consent letter according to the different treatment regiments received by the patients. Baseline information will be collected and relevant test and examination data will be collected at fixed time points after the initiation of treatment. Enrolled patients will be divided into three groups according to treatment regiments: GROUP A, group B and group C. Each group is expected to include 120 subjects, and A total of 360 subjects will be collected Group A: patients in the nucleoside analogues alone group who planned or were receiving entecavir (ETV) tenofovir fumarate (TDF) propofol tenofovir fumarate (TAF) and did not add or switch to peg interferin A-2B program Group B: peG-interferon continuous administration group, subjects were given oral antiviral drugs from day 2 after surgery, and peg-interferon α-2b was combined with peg-interferon α -2B from week 4 to 8 after surgery, until peg-interferon was stopped and antiviral drugs were continued after 96 weeks Group C: polyethylene glycol interferon pulse treatment group, the subjects since 2 days after oral antiviral drugs, at the same time of 4 to 8 week after any point in time with polyethylene glycol interferon alpha 2 b, 8 weeks after stopping each combination (keep continuous oral NA) during 4 weeks, periodic, until weeks after stop using polyethylene glycol (peg) 96 interferon, continue to oral antiviral drugs Follow the instructions for oral antiviral drug administration Patients returned to the study center at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and every 12 weeks thereafter, with a 7-day treatment window and a 15-day follow-up window, until 5 years or study termination Regardless of the reason for discontinuing the study drug therapy, the investigator should try to persuade the patient to continue to complete the 5-year survival follow-up and collect the following information: patient survival status and subsequent treatment options (including targeted therapy, chemotherapy, radiotherapy, surgery and immunotherapy) The primary outcome measures were recurrence free survival (RFS), and the secondary outcome measures were the decrease of HBsAg relative to baseline and the dynamic change of cccDNA clearance rate (OS), which could be used to comprehensively compare the efficacy of combined treatment with peginterferon α-2b after radical surgery

Conditions

• Hepatocellular Carcinoma

Timeline

• Start date: 2021-12-01
• Primary completion: 2027-10-31
• Completion: 2027-12-31
• First posted: 2022-07-20
• Last updated: 2022-07-20

Locations

1 site across 1 country: China