Peg IFNα-2b plus targeted immunotherapy for unresectable HBV-related HCC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, real-world study enrolls about 20 patients with unresectable intermediate to advanced HBV-related hepatocellular carcinoma who are already on nucleoside analog therapy. Eligible participants receive Pegasys in combination with a PD-1 inhibitor or other targeted immunotherapy chosen per CSCO guidelines. Treatments are given in 6-week cycles and continue until disease progression or unacceptable toxicity, with follow-up to monitor safety and outcomes. The study aims to observe efficacy and safety signals in a real-world setting. Primary and secondary endpoints are not specified in the provided summary, but typical measures include tumor response, progression-free survival, overall survival, and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Participants must be aged 18 years or older, with no restrictions on gender.
3. 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).
4. Participants must have at least one measurable lesion, as defined by the RECIST 1.1 criteria.
5. Participants must test positive for serum hepatitis B surface antigen (HBsAg).
6. Participants must have an Eastern Cooperative Oncology Group (ECOG) physical performance status score ranging from 0 to 2.
7. Participants must have an expected survival time of 3 months or longer.
8. 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 Criteria:

1. Known to have had active malignancies other than HCC within the past 5 years or concurrently.
2. Having a documented history of gastrointestinal bleeding or a definite tendency towards gastrointestinal bleeding within 6 months prior to the initiation of study treatment.
3. Patients who have experienced abdominal fistula, gastrointestinal perforation, or intra-peritoneal abscess within 6 months before the commencement of the study treatment.
4. Occurrence of thrombosis or thromboembolic events within 6 months prior to the start of the study treatment.
5. 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).
6. Individuals with a history of severe cardiac disease, especially those with unstable or inadequately controlled cardiac conditions within the preceding 6 months.

Where it's running

• Jinling Hospital, Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Chen chao, Associate Chief Physician
• Email: njjloncologycc@163.com
• Phone: 15950579776

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.