Peginterferon alpha-2b with targeted immunotherapy for advanced liver cancer linked to hepatitis B
Tests peginterferon alpha-2b plus targeted immunotherapy in adults with hepatitis B-related liver cancer.
Plain-language title generated from the registry record
Registry title: Peg IFNα-2b Therapy for Unresectable Mid to Late Stage HBV-HCC
Key facts
- Where
- Nanjing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with hepatitis B-related liver cancer that cannot be removed by surgery and who are already on hepatitis B antiviral treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Hepatocellular carcinoma (liver cancer) at an intermediate or advanced stage that cannot be removed by surgery. Liver function must be Child-Pugh A or B (score ≤ 7). At least one measurable lesion (RECIST 1.1). ECOG performance status 0 to 2. Expected survival of 3 months or longer.
- Earlier treatment
- Must have had nucleoside (nucleotide) analog therapy before and be receiving it now.
- Biomarker or test result
- Positive blood test for hepatitis B surface antigen (HBsAg).
Main reasons for not taking part
- Another active cancer besides liver cancer in the past 5 years or now
- Bleeding in the stomach or gut, or a clear tendency to it, in the past 6 months
- Abdominal fistula, gut perforation or abscess in the abdomen in the past 6 months
- Blood clot or thromboembolic event in the past 6 months
- Mental health disorders such as depression, anxiety, mania or schizophrenia, or such disorders in the family
Read by machine on 9 November 2026.
Where in China
- Jinling Hospital, Nanjing University Medical SchoolNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jinling Hospital, China
- Trial code
- NCT07769827
- Record updated
- 18 August 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: 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; Known to have had active malignancies other than HCC within the past 5 years or concurrently; 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.