Hepatocellular Carcinoma (HCC)PRTRAS 001NCT07120750
Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis
An observational study of Hepatocellular Carcinoma (HCC) and Chronic Hepatitis B, run by Shenzhen Third People's Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Chronic Hepatitis B
- What is being tested?
- Intervention for Group 1 and Intervention for Group 2
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2030
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age: Participants must be between 18 and 70 years of age.
- HBsAg Positive: Participants must be positive for hepatitis B surface antigen (HBsAg).
- Confirmed Hepatocellular Carcinoma (HCC): Participants must have a pathological confirmation of HCC via surgical resection or local ablation.
- BCLC Staging: Participants must have a Barcelona Clinic Liver Cancer (BCLC) staging of 0 or A.
- Liver Function: Participants must have normal or well-compensated liver function, classified as Child-Pugh A.
- Expected Survival: Participants must have an expected survival of more than 3 months.
- Informed Consent: Participants must sign an informed consent form and agree to comply with the study requirements. If a participant is unable to sign the consent form, a legal guardian or agent must do so.
Who cannot join
- Prior Systemic Cancer Treatments: Participants who have received prior systemic cancer treatments such as liver transplantation, chemotherapy, targeted therapy, or biological therapy will be excluded.
- Other Active Malignancies: Participants with a history or presence of other active malignancies, except for skin basal cell carcinoma or squamous cell carcinoma that has been cured, or cervical carcinoma in situ, will be excluded.
- Allergies to Interferon: Participants who are allergic to interferon or any of its components, or whom the investigator deems unsuitable for interferon therapy, will be excluded.
- Other Chronic Liver Diseases: Participants with other chronic liver diseases such as hepatitis A, C, D, or E virus infection, alcoholic liver disease, genetic metabolic liver disease, or drug-induced liver disease will be excluded.
- Autoimmune Diseases:Participants with autoimmune diseases,including autoimmune liver disease and psoriasis, will be excluded.
- Severe Liver Dysfunction: Participants with severe liver dysfunction or decompensated cirrhosis will be excluded.
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- Renal Impairment: Participants with serum creatinine levels exceeding 1.5 times the upper limit of normal will be excluded.
- Severe Systemic Diseases:Participants with severe systemic diseases affecting the heart,lungs,kidneys,brain,or blood will be excluded.
- Severe Neuropsychiatric Disorders:Participants with severe neuropsychiatric disorders such as epilepsy, depression, mania, or schizophrenia will be excluded.
- Unstable Medical Conditions:Participants with unstable diabetes,hypertension,hyperthyroidism,or other endocrine diseases will be excluded.
- Retinopathy:Participants with a history of severe retinopathy or other evidence of retinopathy will be excluded.
- Substance Abuse:Participants with a history of drug abuse or alcoholism will be excluded.
- Pregnancy or Breastfeeding:Pregnant or breastfeeding women, or women planning to become pregnant during the study period who are unwilling to use contraception, will be excluded.
- Investigator's Judgment:Participants whom the investigator deems unsuitable for the study based on their current medical condition will be excluded.
- Concurrent Participation in Other Trials:Participants who are concurrently involved in other clinical research trials will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Different Antiviral Strategies on Tumor Prognosis in Patients With HBV-related Liver Cancer After Radical Treatment: A Prospective, Open-label, Non-randomized Clinical Study
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:
Read more
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.
Read the detailed description
- Study Background The 3-year recurrence rate of HBV-related liver cancer after radical surgery is as high as 40% to 70%. This study aims to explore whether the addition of peginterferon alfa-2b (Peg-IFNα-2b) to nucleoside (acid) analogues (NAs) can reduce the risk of recurrence through immune modulation.
- Key Mechanism Hypotheses Peg-IFNα-2b may reduce the reactivation of micrometastases through:
- Enhancing HBV-specific T-cell responses
- Lowering serum HBsAg levels
- Inhibiting immune suppression in the tumor microenvironment
- Detection Methods
- Imaging Monitoring: Abdominal MRI (using LI-RADS v2018 criteria) every 12 weeks ± 7 days.
- Laboratory Tests:
- HBV DNA: COBAS® TaqMan HBV Test (LLOQ = 10 IU/mL)
- Quantitative HBsAg: Architect HBsAg QT assay
- PBMC Immune Profile: Flow cytometry (proportion of CD8+/PD-1+ T cells)
- Tissue Biomarkers: Postoperative tumor tissue PD-L1 immunohistochemistry (22C3 antibody) and T-cell infiltration score.
- Statistical Design
- Sample size: 332 cases (power 80%, α = 0.05, expected HR = 0.6)
- Primary endpoint analysis: 3-year cumulative recurrence rate (Kaplan-Meier method + Log-rank test)
- Covariate adjustment: Cox model includes age, BCLC stage, and baseline HBsAg level.
- Being tested
- Intervention for Group 1, Intervention for Group 2
- Keywords
- Hepatocellular carcinoma, Peginterferon alfa-2b, Nucleos(t)ide analogues, Post-radical treatment, Clinical cure
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for Group 1Drug
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.
Intervention for Group 2Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Cumulative Recurrence Rate via MRI (LI-RADS)
- 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
- Definition: Proportion of participants with new intrahepatic lesions meeting LI-RADS 5 criteria or histologically confirmed HCC metastases within 3 years post-radical treatment.
- 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)
Measured: 3 years post-radical treatment.
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Throughout the 3-year follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120750
- Sponsor's protocol ID
- IIT-2024-077
- Acronym
- PRTRAS 001
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. 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. 2. 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. 3. 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: 1. Data will be provided in a de-identified format, ensuring participant confidentiality. 2. Along with the data, relevant documentation such as the study protocol, statistical analysis plan, and data dictionary will be made available to facili
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Antiviral Strategies on Tumor Prognosis in Patients With HBV-related Liver Cancer After Radical Treatment: A Prospective, Open-label, Non-randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07120750
- Acronym / sponsor ID
- PRTRAS 001 / IIT-2024-077
- Keywords
- Hepatocellular carcinoma, Peginterferon alfa-2b, Nucleos(t)ide analogues, Post-radical treatment, Clinical cure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2025 (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 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.
Detailed description
- Study Background The 3-year recurrence rate of HBV-related liver cancer after radical surgery is as high as 40% to 70%. This study aims to explore whether the addition of peginterferon alfa-2b (Peg-IFNα-2b) to nucleoside (acid) analogues (NAs) can reduce the risk of recurrence through immune modulation.
- Key Mechanism Hypotheses Peg-IFNα-2b may reduce the reactivation of micrometastases through:
- Enhancing HBV-specific T-cell responses
- Lowering serum HBsAg levels
- Inhibiting immune suppression in the tumor microenvironment
- Detection Methods
- Imaging Monitoring: Abdominal MRI (using LI-RADS v2018 criteria) every 12 weeks ± 7 days.
- Laboratory Tests:
- HBV DNA: COBAS® TaqMan HBV Test (LLOQ = 10 IU/mL)
- Quantitative HBsAg: Architect HBsAg QT assay
- PBMC Immune Profile: Flow cytometry (proportion of CD8+/PD-1+ T cells)
- Tissue Biomarkers: Postoperative tumor tissue PD-L1 immunohistochemistry (22C3 antibody) and T-cell infiltration score.
- Statistical Design
- Sample size: 332 cases (power 80%, α = 0.05, expected HR = 0.6)
- Primary endpoint analysis: 3-year cumulative recurrence rate (Kaplan-Meier method + Log-rank test)
- Covariate adjustment: Cox model includes age, BCLC stage, and baseline HBsAg level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Age: Participants must be between 18 and 70 years of age.
- HBsAg Positive: Participants must be positive for hepatitis B surface antigen (HBsAg).
- Confirmed Hepatocellular Carcinoma (HCC): Participants must have a pathological confirmation of HCC via surgical resection or local ablation.
- BCLC Staging: Participants must have a Barcelona Clinic Liver Cancer (BCLC) staging of 0 or A.
- Liver Function: Participants must have normal or well-compensated liver function, classified as Child-Pugh A.
Key exclusion criteria (15 listed)
- Prior Systemic Cancer Treatments: Participants who have received prior systemic cancer treatments such as liver transplantation, chemotherapy, targeted therapy, or biological therapy will be excluded.
- Other Active Malignancies: Participants with a history or presence of other active malignancies, except for skin basal cell carcinoma or squamous cell carcinoma that has been cured, or cervical carcinoma in situ, will be excluded.
- Allergies to Interferon: Participants who are allergic to interferon or any of its components, or whom the investigator deems unsuitable for interferon therapy, will be excluded.
- Other Chronic Liver Diseases: Participants with other chronic liver diseases such as hepatitis A, C, D, or E virus infection, alcoholic liver disease, genetic metabolic liver disease, or drug-induced liver disease will be excluded.
- Autoimmune Diseases:Participants with autoimmune diseases,including autoimmune liver disease and psoriasis, will be excluded.
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 |
|---|---|---|
| Intervention for Group 1Participants 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. | Drug | – |
| Intervention for Group 2Participants 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. | Drug | – |
Primary outcome
3-Year Cumulative Recurrence Rate via MRI (LI-RADS)
Time frame: 3 years post-radical treatment.
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)
6 secondary outcomes
2-Year HBsAg Seroclearance Rate
Time frame: 2 years post-treatment initiation.
2-Year HBV DNA undetectable rate
Time frame: 2 years post-treatment initiation.
Incidence of Adverse Events (AEs)
Time frame: Throughout the 3-year follow-up period.
Serious Adverse Event (SAE) Rate
Time frame: Throughout the 3-year follow-up period.
Liver Function Deterioration Rate
Time frame: Throughout the 3-year follow-up period.
Quality of Life Change
Time frame: Throughout the 3-year follow-up period.
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 13 Aug 2025.
- Individual participant dataSharing planned: Yes. 1. 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. 2. 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. 3. 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: 1. Data will be provided in a de-identified format, ensuring participant confidentiality. 2. Along with the data, relevant documentation such as the study protocol, statistical analysis plan, and data dictionary will be made available to facili
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Chronic Hepatitis B, run by Shenzhen Third People's Hospital.
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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Qingxian Cai, Doctor (+86-18127814825, 41180423@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Cumulative Recurrence Rate via MRI (LI-RADS) (time frame: 3 years post-radical treatment.). 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 13 Aug 2025.