Peginterferon alfa-2b added to antiviral drugs after liver cancer surgery in hepatitis B
Tests peginterferon alfa-2b plus antivirals in hepatitis B-related liver cancer after surgery.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection
Key facts
- Where
- Hangzhou and Ningbo, ChinaSee the 4 sites
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07553767, who can take part
Where in China
- Shulan（Hangzhou） HospitalHangzhou, ChinaNo longer taking part
- Ningbo Medical Center Lihuili HospitalNingbo, ChinaNo longer taking part
- Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)Ningbo, ChinaNo longer taking part
- Ningbo No.2 HospitalNingbo, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ningbo No.2 Hospital
- Trial code
- NCT07553767
- Record updated
- 28 April 2026
- Original description
The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are:Read full original descriptionShow less
A Non-randomized Controlled, Prospective, Real-world Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection
The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are:
* What are the changes in hepatitis B surface antigen (HBsAg) disappearance rate, HBsAg seroconversion rate, HBsAg decline, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels during treatment and at the end of treatment? * What are the 1-year, 2-year, 3-year, and 5-year recurrence-free survival (RFS) and overall survival (OS) of the included patients? * What are the correlations between changes in HBsAg, T helper 1/T helper 2 (Th1/Th2) subsets, intestinal flora and RFS, OS in these patients?
Researchers will compare Peg-IFN-α-2β combined with NAs to NAs alone to see if the combination treatment can improve HBsAg clearance, seroconversion, long-term survival and reduce recurrence in patients after radical resection of hepatitis B-related hepatocellular carcinoma.
Participants will:
* Receive either Peg-IFN-α-2β combined with first-line NAs (tenofovir disoproxil fumarate [TDF], tenofovir alafenamide fumarate [TAF], tenofovir amibufen fumarate [TMF]) or first-line NAs alone * Undergo regular assessments including HBsAg, HBV DNA, liver and renal function, blood routine, thyroid function, autoantibodies, and tumor markers * Provide stool samples for intestinal flora analysis at specified time points * Complete long-term survival follow-up for up to 5 years
Inclusion: Age 18 to 65 years, male or female; Confirmed diagnosis of hepatitis B virus-related hepatocellular carcinoma (HCC) by pathology or contrast-enhanced CT/MRI; Underwent radical resection or local ablation therapy; CNLC (Chinese Liver Cancer Classification) stage Ia, Ib, or IIa; no residual tumor confirmed by imaging within 1-3 months postoperation; HBsAg positive and HBsAg level < 2000 IU/mL; No prior systemic chemotherapy, immunotherapy, or targeted therapy before enrollment; Able to provide written informed consent and comply with the follow-up schedule; For women of childbearing potential: negative pregnancy test and effective contraception during treatment and for 24 weeks after the last dose.
Exclusion: History of organ transplantation or planned transplantation; Hypersensitivity to peginterferon alfa-2b or any excipient of the study drug; History of significant alcoholism or drug abuse; Genetic or metabolic liver disease (Wilson disease, hemochromatosis, etc.); Coinfection with HAV, HCV, HEV, EBV, CMV , or other viral hepatitis that may interfere with study evaluation; Other conditions deemed inappropriate by the investigator; WBC < 3.5×10⁹/L or platelet count < 100×10⁹/L; ALT > 3×ULN or total bilirubin (TBIL) > 2×ULN; INR > 1.5; Recurrent or metastatic HCC at enrollment; Contraindication to peginterferon alfa-2b treatment; Child-Pugh score > 5 points; Pregnant or breastfeeding women; Participation in another interventional clinical trial; Unable to comply with study procedures and follow-up.