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

Prior treatment

• 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.

Other illness

• 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.

• 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.