Peg IFNα-2b Therapy for Unresectable Mid to Late Stage HBV-HCC

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 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.