NCT07553767Not yet recruitingEarly phase 1
Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection
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
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 29 Mar 2026
- Start date
- 31 Mar 2026
- Primary completion date
- 31 Dec 2034
- Lead sponsor
- Ningbo No.2 Hospital
- NCT number
- NCT07553767
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 156
- From 31 Mar 2026 to the primary completion date, 31 Dec 2034
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- WBC \< 3.5×10⁹/L or platelet count \< 100×10⁹/L.
- ALT \> 3×ULN or total bilirubin (TBIL) \> 2×ULN.
- INR \> 1.5.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shulan（Hangzhou） Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Ningbo Mingzhou Hospital (Affiliated to Zhejiang University) Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.