HBV-HCC
Conditions
Interventions
Control:On the second day after surgery, only the first line of NA (entecavir, TDF or TAF) was administered, one tablet once daily
Experimental group:On the second day after surgery, the first line of NA (entecavir, TDF or TAF) was administered, one tablet once daily
From the third week after surgery, PEG-IFNa-2b was injected with 180µg once a week for 48 weeks
Sponsors
Division of Biliary Surgery, Department of General Surgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the screening period : 1. Life expectancy>= 3 months; 2. Patients with a history of hepatitis B who are currently HBsAg positive and/or HBV-DNA positive; 3. Patients who have undergone hepatectomy guided by ICG fluorescence imaging; 4. CNLC stage IIa or below; 5. ECOG:0-2; 6. Child-Pugh: A; 7. Signed an informed consent form. Inclusion criteria at baseline (3 weeks postoperatively) included: 1. no documented evidence of disease recurrence by computed tomography (CT) scan and CT angiography; 2. a Child-Pugh score of A.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of allergy or is suspected to be allergic to the active ingredient or excipient of the drug under study; 2. Patients taking hepatotoxic drugs or immunosuppressive drugs; 3. CNLC stage IIb or above; 4. Organ transplant recipients; 5. Prior treatment with immunomodulatory agents (e.g., IFN, thymus fascitin) or traditional Chinese medicine within 30 days before randomization; Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to screening, or current infection requiring anti-infective therapy; 6. Patients with clinically significant acute or chronic liver disease not caused by HBV infection (fatty liver disease was ruled out by the investigator); Currently confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophageal and gastric fundus vein flexor bleeding, splenomegaly, ascites, etc. Evidence of progressive liver fibrosis; 7. Patients with previous history of pathological fracture or osteoporosis; 8. The presence of impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs, such as severe gastric ulcers, erosive gastritis, partial gastrectomy, and gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea) lasting more than grade 2; 9. Combined with serious diseases of circulation, respiratory, urinary, blood, metabolism, immunity, mental, nervous, kidney and other systems; 10. Laboratory test: platelet count 2 x ULN; Albumin 1.5 (unless receiving a stable anticoagulant regimen); 11. Hepatitis C antibody positive, HIV antigen/antibody positive, treponema pallidum antibody positive and RPR positive; 12. A history of continuous alcohol abuse within 3 years prior to screening (more than 2 units of alcohol per day on average, 1 unit =10g of alcohol); 13. A history of drug dependence or abuse within 1 year before screening; 14. Positive pregnancy test during lactation or screening period; 15. Subjects with other factors deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2years DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1year and 2years OS;1year DFS;Median time to recurrence;HBsAg clearance;Decrease in HBsAg from baseline; | — |
Countries
China
Contacts
Public ContactLiping Chen
Division of Biliary Surgery, Department of General Surgery, West China Hospital, Sichuan University
Outcome results
None listed