HBV-HCCNCT07769827
Peg IFNα-2b Therapy for Unresectable Mid to Late Stage HBV-HCC
A study testing Combined Peg IFNα-2b treatment group in people with HBV-HCC and Unresectable Advanced HBV-related Liver Cancer, run by Jinling Hospital, China at 1 site in China.
Trial summary
This study is a prospective, real-world study intended to evaluate the efficacy and safety of pegylated interferon alpha-2b (PegIntron®) combined with targeted immunotherapy in patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV-HCC, Unresectable Advanced HBV-related Liver Cancer
- What is being tested?
- Combined Peg IFNα-2b treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 1 Mar 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must voluntarily enroll in the study, demonstrate the ability to understand and voluntarily sign the informed consent form, and adhere to the protocol requirements. In cases where the patient is unable to sign the informed consent form, their legal guardian or authorized agent must sign on their behalf.
- Participants must be aged 18 years or older, with no restrictions on gender.
- Participants must be patients with hepatocellular carcinoma (HCC) who have undergone pathological examination or received a clinical diagnosis, and have been surgically assessed as having intermediate or advanced unresectable HCC, with liver function classified as Child-Pugh A or B (score ≤ 7).
- Participants must have at least one measurable lesion, as defined by the RECIST 1.1 criteria.
- Participants must test positive for serum hepatitis B surface antigen (HBsAg).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) physical performance status score ranging from 0 to 2.
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- Participants must have an expected survival time of 3 months or longer.
- Participants must exhibit good organ function levels within one week prior to the first administration of the study drug, as evaluated by the investigator.
- For females of childbearing potential, a negative pregnancy test result must be obtained within one week prior to the first administration of the study drug.
Who cannot join
- Known to have had active malignancies other than HCC within the past 5 years or concurrently.
- Having a documented history of gastrointestinal bleeding or a definite tendency towards gastrointestinal bleeding within 6 months prior to the initiation of study treatment.
- Patients who have experienced abdominal fistula, gastrointestinal perforation, or intra-peritoneal abscess within 6 months before the commencement of the study treatment.
- Occurrence of thrombosis or thromboembolic events within 6 months prior to the start of the study treatment.
- Individuals with neuropsychiatric disorders, particularly those with a history of depression, anxiety, mania, schizophrenia, or a familial history of psychiatric disorders (especially those with a history of depression or a predisposition to depression).
- Individuals with a history of severe cardiac disease, especially those with unstable or inadequately controlled cardiac conditions within the preceding 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Nanjing University Medical School
Nanjing, Jiangsu
About this study
Official title: Preliminary Efficacy and Safety of Pegylated Interferon Alpha-2b Combined With Targeted Immunotherapy in Patients With Unresectable Advanced Chronic Hepatitis B-related Hepatocellular Carcinoma: a Prospective, Real-world Study
This study is a prospective, real-world study intended to evaluate the efficacy and safety of pegylated interferon alpha-2b (PegIntron®) combined with targeted immunotherapy in patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma.
This study intends to enroll 20 patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma who have previously undergone and are currently receiving nucleoside (nucleotide) analog therapy. Subjects who meet the inclusion and exclusion criteria after evaluation will receive Pegasys® combined with targeted immunotherapy. Both targeted therapy and PD-1 inhibitors will be selected based on actual clinical decision-making, using standard therapeutic drugs recommended by the CSCO guidelines. During the study, each 6 weeks will be defined as a treatment cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. Follow-up will be completed according to the protocol until the end of the study.
- Being tested
- Combined Peg IFNα-2b treatment group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Peg IFNα-2b treatment groupBiological
On the basis of conventional treatment, combined with Peg IFNα-2b
| Study group | Role | What they receive |
|---|---|---|
| Peg IFNα-2b combined with PD-1 inhibitor and targeted therapy | Experimental | Not described Receives: Biological: Combined Peg IFNα-2b treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year progression-free survival after treatment
The proportion of patients who have not progressed or died from any cause within one year after the start of treatment.
Measured: At 1 year
Overall Survival (OS)
From first dose of treatment to date of death due to any cause, assessed up to 36 months.
Measured: From first dose of treatment to date of death due to any cause, assessed up to 36 months.
Secondary outcomes (6)
Objective Response Rate (ORR)
The best overall response, defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. Confirmed response requires tumor shrinkage to be confirmed at least 4 weeks after the initial documentation of response.
Measured: At the time of best overall response, assessed up to 24 months.
HBsAg level, magnitude of decrease from baseline, kinetics, negativity rate (<0.05 IU/mL), and seroconversion rate
The change from baseline in HBsAg level, including the magnitude of decrease, kinetics, the rate of negativity (<0.05 IU/mL), and the rate of seroconversion.
Measured: At baseline, Week 12, Week 24, Week 36, Week 48, and Week 96
Disease Control Rate (DCR)
The best overall response, defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). For patients with SD, the response must be confirmed at least 12 weeks after the first dose of treatment.
Measured: From baseline until the end of treatment or disease progression, assessed up to 24 months.
HBV DNA levels, magnitude of decrease from baseline, and proportion of subjects with undetectable levels (among HBV DNA-positive patients)
To evaluate HBV DNA levels, the magnitude of decrease from baseline, and the proportion of subjects with undetectable levels among HBV DNA-positive patients.
Measured: At baseline, Week 12, Week 24, Week 48, and Week 96.
HBeAg levels, magnitude of decrease from baseline, seroconversion rate, and negativity rate (among HBeAg-positive patients)
To evaluate HBeAg levels, the magnitude of decrease from baseline, seroconversion rate, and negativity rate among HBeAg-positive patients.
Measured: t baseline, Week 12, Week 24, Week 48, and Week 96.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score from Baseline
To evaluate the change in ECOG Performance Status Score from baseline.
Measured: At baseline, Week 12, Week 24, Week 48, and Week 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start26 Dec 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV-HCCStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sizhen Wang, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769827
- Sponsor's protocol ID
- Peg IFNα-2b treat for HBV-HCC
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy and Safety of Pegylated Interferon Alpha-2b Combined With Targeted Immunotherapy in Patients With Unresectable Advanced Chronic Hepatitis B-related Hepatocellular Carcinoma: a Prospective, Real-world Study
- ClinicalTrials.gov ID
- NCT07769827
- Acronym / sponsor ID
- Peg IFNα-2b treat for HBV-HCC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 18 Aug 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.
This study is a prospective, real-world study intended to evaluate the efficacy and safety of pegylated interferon alpha-2b (PegIntron®) combined with targeted immunotherapy in patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma.
This study intends to enroll 20 patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma who have previously undergone and are currently receiving nucleoside (nucleotide) analog therapy. Subjects who meet the inclusion and exclusion criteria after evaluation will receive Pegasys® combined with targeted immunotherapy. Both targeted therapy and PD-1 inhibitors will be selected based on actual clinical decision-making, using standard therapeutic drugs recommended by the CSCO guidelines. During the study, each 6 weeks will be defined as a treatment cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. Follow-up will be completed according to the protocol until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg IFNα-2b combined with PD-1 inhibitor and targeted therapy | Experimental | Biological: Combined Peg IFNα-2b treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must voluntarily enroll in the study, demonstrate the ability to understand and voluntarily sign the informed consent form, and adhere to the protocol requirements. In cases where the patient is unable to sign the informed consent form, their legal guardian or authorized agent must sign on their behalf.
- Participants must be aged 18 years or older, with no restrictions on gender.
- Participants must be patients with hepatocellular carcinoma (HCC) who have undergone pathological examination or received a clinical diagnosis, and have been surgically assessed as having intermediate or advanced unresectable HCC, with liver function classified as Child-Pugh A or B (score ≤ 7).
- Participants must have at least one measurable lesion, as defined by the RECIST 1.1 criteria.
- Participants must test positive for serum hepatitis B surface antigen (HBsAg).
Key exclusion criteria (6 listed)
- Known to have had active malignancies other than HCC within the past 5 years or concurrently.
- Having a documented history of gastrointestinal bleeding or a definite tendency towards gastrointestinal bleeding within 6 months prior to the initiation of study treatment.
- Patients who have experienced abdominal fistula, gastrointestinal perforation, or intra-peritoneal abscess within 6 months before the commencement of the study treatment.
- Occurrence of thrombosis or thromboembolic events within 6 months prior to the start of the study treatment.
- Individuals with neuropsychiatric disorders, particularly those with a history of depression, anxiety, mania, schizophrenia, or a familial history of psychiatric disorders (especially those with a history of depression or a predisposition to depression).
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 |
|---|---|---|
| Combined Peg IFNα-2b treatment groupOn the basis of conventional treatment, combined with Peg IFNα-2b | Biological | Peg IFNα-2b combined with PD-1 inhibitor and targeted therapy |
Primary outcome
One-year progression-free survival after treatment
Time frame: At 1 year
The proportion of patients who have not progressed or died from any cause within one year after the start of treatment.
Overall Survival (OS)
Time frame: From first dose of treatment to date of death due to any cause, assessed up to 36 months.
From first dose of treatment to date of death due to any cause, assessed up to 36 months.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: At the time of best overall response, assessed up to 24 months.
HBsAg level, magnitude of decrease from baseline, kinetics, negativity rate (<0.05 IU/mL), and seroconversion rate
Time frame: At baseline, Week 12, Week 24, Week 36, Week 48, and Week 96
Disease Control Rate (DCR)
Time frame: From baseline until the end of treatment or disease progression, assessed up to 24 months.
HBV DNA levels, magnitude of decrease from baseline, and proportion of subjects with undetectable levels (among HBV DNA-positive patients)
Time frame: At baseline, Week 12, Week 24, Week 48, and Week 96.
HBeAg levels, magnitude of decrease from baseline, seroconversion rate, and negativity rate (among HBeAg-positive patients)
Time frame: t baseline, Week 12, Week 24, Week 48, and Week 96.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score from Baseline
Time frame: At baseline, Week 12, Week 24, Week 48, and Week 96.
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 18 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Peg IFNα-2b treatment group in people with HBV-HCC and Unresectable Advanced HBV-related Liver Cancer, run by Jinling Hospital, China at 1 site 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Chen chao, Associate Chief Physician (15950579776, njjloncologycc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year progression-free survival after treatment (time frame: At 1 year). The study lists 2 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 18 Aug 2026.