Antiviral Therapy for Patients With Liver Cancer After Surgery

NCT ID: NCT05466565

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 1. Are receiving hepatotoxic drugs, immunosuppressants or targeted drug therapy, or receiving adjuvant chemotherapy after surgery; 2. Past or concurrent with other malignant tumors, except for cured skin basal cell or squamous cell carcinoma and cervical carcinoma in situ; 3. Those who are allergic to interferon alpha and its drug components, and those who are judged by the investigator to be unsuitable for the use of interferon alpha; 4. Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug-induced liver disease, non-alcoholic fatty liver disease and other chronic liver diseases; combined with autoimmune diseases, including autoimmune liver disease, Psoriasis, etc.; 5. Neutrophil count < 1.5 x 109 cells/L or platelet count < 80 x 109 cells/L; 6. Creatinine is higher than 1.5 times the upper limit of normal; 7. Patients with serious diseases of the heart, lung, kidney, brain, blood and other important organs; 8. Patients with severe neurological and psychiatric diseases (such as epilepsy, depression, mania, seizures, schizophrenia, etc.); 9. Unstable control of diabetes, hypertension, thyroid disease, etc.; history of severe retinopathy or patients with retinopathy shown by other evidence; 10. Child-Pugh is graded C; 11. Drug abuse or alcoholism; 12. Infection, hemorrhage or other postoperative complications deemed unsuitable to participate in the study during the baseline examination; the baseline examination indicates the recurrence and metastasis of liver cancer; 13. Pregnant or breastfeeding women or patients who have a pregnancy plan and are unwilling to contracept during the study period; 14. The investigator believes that the subject's current condition is not suitable for participating in this study; 15. Patients who participate in other clinical research trials at the same time.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ledu Zhou, PhD student

Role: STUDY_CHAIR

Xiangya Hospital of Central South University

Locations

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ledu Zhou, PhD student

Role: CONTACT

zhould@csu.edu.cn

17373120367

Facility Contacts

Ledu Zhou, PhD

Role: primary

zhould@csu.edu.cn

17373120367

Other Identifiers

XiangyaHGRS

Identifier Type: -

Identifier Source: org_study_id