Hepatocellular CarcinomaEarly Phase 1NCT07553767
Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection
A Early Phase 1 study testing Peginterferon alfa-2b, TDF and TAF in people with Hepatocellular Carcinoma and HEPATITIS B CHRONIC, run by Ningbo No.2 Hospital at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma, HEPATITIS B CHRONIC, Hepatitis B Chronic Infection
- What is being tested?
- Peginterferon alfa-2b, TDF and TAF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 4 sitesChina
- Study dates
- 31 Mar 2026to 31 Dec 2035
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Recurrent or metastatic HCC at enrollment.
- Contraindication to peginterferon alfa-2b treatment.
- WBC < 3.5×10⁹/L or platelet count < 100×10⁹/L.
- ALT > 3×ULN or total bilirubin (TBIL) > 2×ULN.
- Child-Pugh score > 5 points.
- INR > 1.5.
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- History of organ transplantation or planned transplantation.
- Hypersensitivity to peginterferon alfa-2b or any excipient of the study drug.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial.
- 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.
- Unable to comply with study procedures and follow-up.
- Other conditions deemed inappropriate by the investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310022
Liyun Fu, +86 13777966906, nbfly2009@126.com
Mengyuan Hu, +86 17858767819, hmy_helen@163.com
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Liyun Fu, +86 13777966906, nbfly2009@126.com
Mengyuan Hu, +86 17858767819, hmy_helen@163.com
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
Ningbo, Zhejiang, 315000
Liyun Fu, +86 13777966906, nbfly2009@126.com
Mengyuan Hu, +86 17858767819, hmy_helen@163.com
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315000
Liyun Fu, +86 13777966906, nbfly2009@126.com
Mengyuan Hu, +86 17858767819, hmy_helen@163.com
About this study
Official title: 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?
Read more
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
- Being tested
- Peginterferon alfa-2b, TDF, TAF, TMF
- Keywords
- Peg-IFN-α-2b, hepatitis B, hepatocellular carcinoma, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2bDrug
Peginterferon alfa-2b injection administered subcutaneously
TDFDrug
Tenofovir disoproxil fumarate
TAFDrug
Tenofovir alafenamide
TMFDrug
Tenofovir amibufenamide
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa-2b combined with NAs | Experimental | Patients receive peginterferon alfa-2b (Pegintron®) combined with first-line nucleos(t)ide analogues (TDF/TAF/TMF) Receives: Drug: Peginterferon alfa-2b; Drug: TDF; Drug: TAF; Drug: TMF |
| NAs alone | Active comparator | Patients receive first-line nucleos(t)ide analogues (TDF/TAF/TMF) alone Receives: Drug: TDF; Drug: TAF; Drug: TMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg)
Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA).
Unit: IU/mL
Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Proportion of patients with HBsAg loss
Proportion of patients with HBsAg loss (HBsAg < 0.05 IU/mL) determined by CMIA. Unit: % of patients
Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Proportion of patients with HBsAg seroconversion
Proportion of patients with HBsAg loss (HBsAg < 0.05 IU/mL) and anti-HBs seropositivity (anti-HBs ≥ 10 mIU/mL) determined by CMIA.
Unit: % of patients
Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Secondary outcomes (11)
Concentration of HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid)
Serum HBV DNA viral load quantified by a TaqMan-based real-time quantitative polymerase chain reaction (qPCR) assay.
Unit: IU/mL
Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Concentration of Hepatitis B e Antigen (HBeAg)
Serum HBeAg concentration assessed by CMIA. Unit: S/CO
Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Composition and diversity of intestinal microbiota
Intestinal microbiota analyzed by 16S rRNA gene high-throughput sequencing. Unit: Relative abundance (%) and alpha diversity index
Measured: Baseline, Week 24, Week 48
Recurrence-Free Survival (RFS)
Time to first hepatocellular carcinoma (HCC) recurrence or death from any cause, which is confirmed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).
Unit: Months
Measured: Years 1, 2, 3, 5
Overall survival (OS)
Time from enrollment to death from any cause, regardless of the cause of death. Unit: Months
Measured: Years 1, 2, 3, 5
Concentration of Interleukin-2 (IL-2)
Serum levels of IL-2 will be measured using cytometric bead array (CBA). Unit: pg/mL
Measured: Baseline, Week 24, Week 48
Concentration of Interleukin-4 (IL-4)
Serum levels of IL-4 will be measured using cytometric bead array (CBA). Unit: pg/mL
Measured: Baseline, Week 24, Week 48
Concentration of Interleukin-6 (IL-6)
Serum levels of IL-6 will be measured using cytometric bead array (CBA). Unit: pg/mL
Measured: Baseline, Week 24, Week 48
Concentration of Interleukin-10 (IL-10)
Serum levels of IL-10 will be measured using cytometric bead array (CBA). Unit: pg/mL
Measured: Baseline, Week 24, Week 48
Concentration of Tumor Necrosis Factor-α (TNF-α)
Serum levels of TNF-α will be measured using cytometric bead array (CBA). Unit: pg/mL
Measured: Baseline, Week 24, Week 48
Concentration of Interferon-γ (IFN-γ)
Serum levels of IFN-γ will be measured using cytometric bead array (CBA). Unit: pg/mL
Measured: Baseline, Week 24, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No.2 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital, Ningbo Mingzhou Hospital (Affiliated to Zhejiang University), Shulan (Hangzhou) Hospital
- Responsible party
- Principal investigator, Liyun Fu, Ningbo No.2 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553767
- Sponsor's protocol ID
- PJ-NBEY-KY-2025-215-01
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not planned for this investigator-initiated study. Data will be used only for the primary study analysis and reporting.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07553767
- Acronym / sponsor ID
- PJ-NBEY-KY-2025-215-01
- Keywords
- Peg-IFN-α-2b, hepatitis B, hepatocellular carcinoma, prognosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Ningbo No.2 HospitalUniversity, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital, Ningbo Mingzhou Hospital (Affiliated to Zhejiang University), Shulan (Hangzhou) Hospital
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa-2b combined with NAs | Experimental | Drug: Peginterferon alfa-2b, Drug: TDF, Drug: TAF, Drug: TMFPatients receive peginterferon alfa-2b (Pegintron®) combined with first-line nucleos(t)ide analogues (TDF/TAF/TMF) |
| NAs alone | Active comparator | Drug: TDF, Drug: TAF, Drug: TMFPatients receive first-line nucleos(t)ide analogues (TDF/TAF/TMF) alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- Recurrent or metastatic HCC at enrollment.
- Contraindication to peginterferon alfa-2b treatment.
- WBC < 3.5×10⁹/L or platelet count < 100×10⁹/L.
- ALT > 3×ULN or total bilirubin (TBIL) > 2×ULN.
- Child-Pugh score > 5 points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2bPeginterferon alfa-2b injection administered subcutaneously | Drug | Peginterferon alfa-2b combined with NAs |
| TDFTenofovir disoproxil fumarate | Drug | NAs alone, Peginterferon alfa-2b combined with NAs |
| TAFTenofovir alafenamide | Drug | NAs alone, Peginterferon alfa-2b combined with NAs |
| TMFTenofovir amibufenamide | Drug | NAs alone, Peginterferon alfa-2b combined with NAs |
Primary outcome
Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg)
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA). Unit: IU/mL
Proportion of patients with HBsAg loss
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Proportion of patients with HBsAg loss (HBsAg < 0.05 IU/mL) determined by CMIA. Unit: % of patients
Proportion of patients with HBsAg seroconversion
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Proportion of patients with HBsAg loss (HBsAg < 0.05 IU/mL) and anti-HBs seropositivity (anti-HBs ≥ 10 mIU/mL) determined by CMIA. Unit: % of patients
11 secondary outcomes
Concentration of HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid)
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Concentration of Hepatitis B e Antigen (HBeAg)
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Composition and diversity of intestinal microbiota
Time frame: Baseline, Week 24, Week 48
Recurrence-Free Survival (RFS)
Time frame: Years 1, 2, 3, 5
Overall survival (OS)
Time frame: Years 1, 2, 3, 5
Concentration of Interleukin-2 (IL-2)
Time frame: Baseline, Week 24, Week 48
Concentration of Interleukin-4 (IL-4)
Time frame: Baseline, Week 24, Week 48
Concentration of Interleukin-6 (IL-6)
Time frame: Baseline, Week 24, Week 48
Concentration of Interleukin-10 (IL-10)
Time frame: Baseline, Week 24, Week 48
Concentration of Tumor Necrosis Factor-α (TNF-α)
Time frame: Baseline, Week 24, Week 48
Concentration of Interferon-γ (IFN-γ)
Time frame: Baseline, Week 24, Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. IPD sharing is not planned for this investigator-initiated study. Data will be used only for the primary study analysis and reporting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Peginterferon alfa-2b, TDF and TAF in people with Hepatocellular Carcinoma and HEPATITIS B CHRONIC, run by Ningbo No.2 Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyun Fu (+86 13777966906, nbfly2009@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg) (time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.