Hepatitis B virus infection of hepatocellular carcinoma
Conditions
Interventions
IFN a-2b combined with NAs group:Add IFN a-2b treatment on the basis of NA treatment
NAs group:Oral NAs
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, able to understand and sign informed consent; 2. Age of 18-65 years old (including 18 and 65), regardless of gender; 3. Expected survival time >=24 months; 4. HBsAg positive at screening; 5. Patients with HCC confirmed by histopathological examination or imaging criteria; 6.Child-Pugh grade A; 7. Preoperative imaging evaluation of single tumor =90g/L and platelet count (PLT) >=50×10^9/L during screening; Absolute neutrophil count > 1.0×10^9/L; Prothrombin activity (PTA) > 50%; Serum creatinine < 1.5×ULN; ALT < 10×ULN; Total bilirubin (TBIL) < 3×ULN; 10. Negative pregnancy test (female of childbearing age) within 24 hours before the first dose of medication; The subjects (male and female subjects) should take effective contraceptive measures during the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women or those with fertility plans during the study period; 2.Patients with portal/ductal/liver vein tumor thrombus, vascular invasion, extrahepatic metastasis, liver transplant patients; 3.Those who have received or are about to receive chemotherapy and/or molecular targeted therapy; 4.Those who are about to receive immunotherapy or other anti-tumor treatments; 5.Patients with neuro-psychiatric disorders, especially those with a history of depression, anxiety, mania, schizophrenia or other mental disorders, or a family history of mental disorders (especially a history of depression or a tendency towards depression); 6.Combine current infections of hepatitis A, hepatitis B, hepatitis C, hepatitis D, and/or HIV; 7.Chronic liver diseases caused by other reasons, such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver diseases; 8.Severe fatty hepatitis; 9.Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or with serum creatinine > 1.5 × ULN at the time of screening; 10.Serum phosphorus 1:100; 12.Autoimmune diseases, including psoriasis, systemic lupus erythematosus, etc.; 13.Endocrine system diseases, including thyroid diseases, diabetes, etc.; 14.Hypertension not controlled by prescribed medication (blood pressure >= 140/90 mmHg); 15.History of severe heart disease, especially unstable or poorly controlled heart disease within 6 months; 16.Severe retinal diseases or other serious ocular diseases; 17.Other organic lesions or functional impairments of important organs; 18.Those planning to undergo organ transplantation or who have already undergone organ transplantation; 19.Allergic to interferons, nucleoside (acid) analogues, or drug excipients, or those who meet any of the contraindications stated in the instructions for use of the investigational drug; 20.Other situations that occurred within 3 months before screening and that the investigator deems unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence-free survival rate two years after complete ablation (96 + 4 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| The recurrence-free survival period and time (RFS) at 1 year, 3 years, and 5 years after complete ablation surgery;Polyethylene glycol interferon a-2b injection combined with NAs for 1-year treatment: changes in HBsAg levels, HBV DNA seroconversion rate, and serological changes of HBeAg;Change in Child-Pugh classification one year after complete ablation surgery;The overall survival rate and time (OS) at 1 year, 2 years, 3 years and 5 years after complete ablation surgery; | — |
Countries
China
Contacts
Public ContactChunwang Yuan
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed