Hepatitis B associated hepatocellular carcinoma
Conditions
Interventions
Peginterferon a-2b based group:Peg IFN-a2b injection, subcutaneous injection 180 mcg, once a week,for 48 weeks.
NAs, according to the standard dosage of each drug, once a day,for 48 weeks.
If HBsAg n
NAs monotherapy group:First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), each drug is taken orally once a
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary enrollment, with the ability to understand and sign the informed consent form. 2.Aged 18–70 years (inclusive), regardless of gender. 3.High-risk cohort for HBV-related HCC (all of the following criteria must be met): (1) Cohort of patients with compensated hepatitis B cirrhosis: Diagnosis of compensated cirrhosis is based on meeting one of the following two criteria: 1) Histopathological confirmation of cirrhosis; or 2) Meeting two or more of the following five criteria, with non-cirrhotic portal hypertension excluded: Imaging findings indicating cirrhosis and/or signs of portal hypertension; Endoscopic evidence of esophageal or gastric varices; Liver stiffness measurement (LSM) consistent with cirrhosis (LSM >12.0 kPa when ALT 17.0 kPa when 1× ULN 3 seconds above the control); Complete blood count showing platelet count <100 × 10?/L. (2) Cohort of HBsAg-positive patients with HBV-related HCC after radical resection (all of the following criteria must be met): 1) Diagnosis of HCC confirmed by histopathology or imaging (contrast-enhanced CT or MRI); 2) Patients who have undergone radical surgery must meet the following criteria: Preoperative HCC staging: CNLC stage Ia, Ib, or IIa; Radical surgery includes either of the following: Surgical radical resection; Ablation-based interventional procedures. Criteria for no recurrence: Follow-up examinations (ultrasound, contrast-enhanced CT, or MRI of the liver) at 1–3 months post-surgery show no tumor lesions or arterial phase enhancing lesions. For patients with elevated serum AFP levels preoperatively, AFP levels must return to normal within 2 months post-surgery. (3) HBsAg-positive. 4.Negative pregnancy test (for women of childbearing potential) within 24 hours prior to the first dose in the treatment group. Both male and female participants must use effective contraception during the study and for 24 weeks after discontinuation of the study treatment.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (Subjects meeting any one of the following criteria will be excluded): 1.Patients with tumor recurrence or metastasis prior to treatment. 2.Patients with contraindications to Pegylated Interferon-alpha (Peg-IFN-a) therapy (refer to the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details). 3.Peripheral blood count: WBC 10×ULN or TBIL > 2×ULN. 5.Prothrombin time, expressed as International Normalized Ratio (INR) > 1.5. 6.Patients planning to undergo or who have previously undergone organ transplantation. 7.Patients with a known allergy to interferon or any contraindication listed in the investigational product’s prescribing information/package insert. Any other condition that, in the investigator’s opinion, makes the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of liver cancer during Peg-IFN-a2b use and at 48 weeks after completion of treatment compared with control group;Proportion of HDN nodules disappeared during and after treatment with Peg-IFN-a2b in treatment group compared with control group;HCC recurrence rate during Peg-IFN-a2b treatment and 48 weeks after completion of treatment compared with control group.;HBsAg negative and conversion rates during Peg-IFN-a2b therapy and follow up in the treatment group compared with the control group.;Serum conversion rates during Peg-IFN-a2b therapy and follow up in the treatment group compared with the control group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Both cohorts: the incidence of liver cancer at week 96 and week 144 after Peg-IFN-a2b treatment in the treatment group was compared with the control group.;Both cohorts: liver cancer recurrence rates at week 96 and week 144 after Peg-IFN-a2b treatment in the treatment group were compared with those in the control group.;Both cohorts: compared with the control group, patients in the treatment group were treated with Peg-IFN-a2b for HBV DNA at weeks 12, 24, 36, 48, 72, 96 and 12, 24, 48, 72, 96, 120, 144 after treatment.;Both cohorts: compared with the control group, patients in the treatment group were treated with Peg-IFN-a2b for HBsAg levels at weeks 12, 24, 36, 48, 72, 96 and 12, 24, 48, 72, 96, 120, 144 after treatment.;Both cohorts: compared with the control group, patients in the treatment group were treated with Peg-IFN-a2b for incidence of decompensated cirrhosis at weeks 12, 24, 36, 48, 72, 96 and 12, 24, 48, 72, 96, 120, 144 after treatment.; | — |
Countries
China
Contacts
Public ContactXiaoguang Dou
Shengjing Hospital of China Medical University
Outcome results
None listed