An observational study in Hepatocellular Carcinoma (HCC) and Chronic Hepatitis B, sponsored by Shenzhen Third People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Shenzhen Third People's Hospital · Observational
The goal of this clinical trial is to learn if peginterferon alfa-2b can reduce the recurrence of HBV-related liver cancer in patients who have undergone radical treatment. The study will also explore the potential benefits of peginterferon alfa-2b in achieving clinical cure and its impact on reducing liver cancer recurrence.
The trial is designed as a single-center, non-randomized, open-label study. Participants will be HBV-related liver cancer patients who have received radical treatment. The study will compare two groups: one receiving nucleos(t)ide analogues (NAs) alone and the other receiving NAs combined with peginterferon alfa-2b. The main question it aims to answer is:
Can peginterferon alfa-2b lower the 3-year recurrence rate in HBV-related liver cancer patients after radical treatment?
Participants will undergo regular follow-ups, including imaging studies and blood tests, to monitor for cancer recurrence and assess the safety of the treatment.
Key Mechanism Hypotheses
Peg-IFNα-2b may reduce the reactivation of micrometastases through:
Detection Methods
Statistical Design
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 332 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Shenzhen Third People's Hospital is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population comprises adults aged 18 to 70 with HBV-related liver cancer who have undergone radical treatment (surgery or ablation). They are HBsAg-positive, with pathological confirmation of HCC and BCLC staging of 0 or A. Participants must have adequate liver function (Child-Pugh A), an expected survival of over 3 months, and provide informed consent. The study excludes those with prior systemic cancer treatments, other active malignancies, allergies to interferon, severe liver or renal dysfunction, and other significant health issues.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard NAs therapy, which may include entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF). NAs are antiviral medications used to suppress HBV replication and manage chronic hepatitis B infection.
Participants will receive Peg-IFNα-2b in addition to NAs therapy. Peg-IFNα-2b is an antiviral medication that works by boosting the immune system and has additional antiviral, antifibrotic, and anti-tumor effects. It is used to treat chronic hepatitis B and may help reduce the recurrence of liver cancer.
3-Year Cumulative Recurrence Rate via MRI (LI-RADS)
1. Measurement Tool: Liver Imaging Reporting and Data System (LI-RADS v2018) 1.1 Primary modality: Dynamic contrast-enhanced MRI 1.2 Confirmatory criteria: 1.2.1 LI-RADS 5 (definite HCC): 1.2.1.1 Arterial hyperenhancement + 1.2.1.2 Portal venous washout ± 1.2.1.3 Capsule/threshold growth 1.2.2 Histopathology (biopsy) for equivocal cases 2. Definition: Proportion of participants with new intrahepatic lesions meeting LI-RADS 5 criteria or histologically confirmed HCC metastases within 3 years post-radical treatment. 3. Clinical Significance: Recurrence defined as: 3.1 Local (original site) 3.2 Intrahepatic (\>2 cm from resection margin) 3.3 Extrahepatic (metastases with biopsy confirmation)
Time frame: 3 years post-radical treatment.
2-Year HBsAg Seroclearance Rate
* Measurement Tool: Architect HBsAg QT Assay * Definition: Proportion with HBsAg loss (\<0.05 IU/mL) * Directionality: Lower HBsAg levels indicate better response * Confirmation: Required at two timepoints ≥24 weeks apart
Time frame: 2 years post-treatment initiation.
2-Year HBV DNA undetectable rate
* Measurement Tool: COBAS® TaqMan HBV Test v2.0 * Definition: Proportion of participants achieving HBV DNA \<10 IU/mL (LLOQ) in two consecutive tests ≥6 months apart * Directionality: Lower values indicate better virological control
Time frame: 2 years post-treatment initiation.
Incidence of Adverse Events (AEs)
* Measurement Tool: CTCAE v5.0 grading system * Definition: Frequency of all-cause AEs, categorized by: * Severity: Grade 1 (mild) to 5 (death) * Relatedness: Definite/probable/possible vs. unrelated * Range: 1-5 scale (higher grade = worse severity) * Reporting Threshold: All events ≥Grade 2
Time frame: Throughout the 3-year follow-up period.
Serious Adverse Event (SAE) Rate
* Measurement Tool: CTCAE v5.0 * Definition: Events meeting ≥1 SAE criterion: Death/life-threatening Hospitalization/prolonged hospitalization Persistent disability Congenital anomaly -Causality Assessment: Using WHO-UMC system
Time frame: Throughout the 3-year follow-up period.
Liver Function Deterioration Rate
* Measurement tool: Change in Child-Pugh score ≥ 2 points * Range: 5 - 15 points (the higher the score, the worse the liver function) * Definition: The proportion of patients with an increase in Child-Pugh score of ≥ 2 points during treatment compared to the baseline.
Time frame: Throughout the 3-year follow-up period.
Quality of Life Change
* Measurement tool: EORTC QLQ-C30 * Range: 0-100 (higher scores on functional dimensions indicate better status; higher scores on symptom dimensions indicate worse status) * Definition: Change from baseline in global health status/QoL over 3 years, analyzed with a mixed-effects linear model.
Time frame: Throughout the 3-year follow-up period.
No study locations are listed for this record.
Plan to share: Yes — Data Availability: De-identified individual participant data will be made available upon reasonable request after the completion of the study and publication of the primary results. Time Frame: Data will be available starting from six months after the publication of the primary study results and for a period of five years thereafter. Access Criteria: (1) Requests for data access will be reviewed by the study's data monitoring committee. (2) Data will be shared for research purposes that are consistent with the original study objectives and for the advancement of scientific knowledge. (3) Researchers requesting access must submit a detailed proposal outlining their research question, methods, and analysis plan. 4. Data Sharing Process: Data will be provided in a de-identified format, ensuring participant confidentiality. Along with the data, relevant documentation such as the study protocol, statistical analysis plan, and data dictionary will be made available to facili
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Start Date: Six months after the publication of the primary study results. End Date: Five years following the start date. Description: "De-identified individual participant data will be available starting six months after the publication of the primary study results and for a period of five years thereafter."
Access criteria: Who Can Access: Researchers who submit a valid research proposal outlining a scientific objective that is consistent with the original study aims. What Can Be Accessed: De-identified dataset along with relevant study documentation (e.g., protocol, statistical analysis plan, data dictionary). How to Access: By submitting a formal request to the principal investigator, including a detailed research proposal and data usage plan. Access will be granted upon approval by the study's data monitoring committee. Description: "Access to the de-identified individual participant data and supporting documentation will be granted to qualified researchers upon approval of a formal request and research proposal. Researchers must demonstrate that their objectives align with the original study's scope."
Data sharing details ↗ · www.szsdsrmyy.com
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Dec 2029, 51 months later.
Of 302 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 114. This study's planned 51 months is close to that.
Counting every sponsor, half of 351 studies reached it within 51 months; a quarter within 32 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Shenzhen Third People's Hospital