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

NCT07769827 | Recruiting

• 1 other identifier: Peg IFNα-2b treat for HBV-HCC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV-HCC; Unresectable Advanced HBV-related Liver Cancer

Outcome Measures

Primary Outcomes (2)

• One-year progression-free survival after treatment

  The proportion of patients who have not progressed or died from any cause within one year after the start of treatment.

  At 1 year

• Overall Survival (OS)

  From first dose of treatment to date of death due to any cause, assessed up to 36 months.

  From first dose of treatment to date of death due to any cause, assessed up to 36 months.

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  At the time of best overall response, assessed up to 24 months.

• HBsAg level, magnitude of decrease from baseline, kinetics, negativity rate (<0.05 IU/mL), and seroconversion rate

  At baseline, Week 12, Week 24, Week 36, Week 48, and Week 96

• Disease Control Rate (DCR)

  From baseline until the end of treatment or disease progression, assessed up to 24 months.

• HBV DNA levels, magnitude of decrease from baseline, and proportion of subjects with undetectable levels (among HBV DNA-positive patients)

  At baseline, Week 12, Week 24, Week 48, and Week 96.

• HBeAg levels, magnitude of decrease from baseline, seroconversion rate, and negativity rate (among HBeAg-positive patients)

  t baseline, Week 12, Week 24, Week 48, and Week 96.

Study Arms (1)

Peg IFNα-2b combined with PD-1 inhibitor and targeted therapy

EXPERIMENTAL

Biological: Combined Peg IFNα-2b treatment group

Interventions

Combined Peg IFNα-2b treatment group BIOLOGICAL

On the basis of conventional treatment, combined with Peg IFNα-2b

Peg IFNα-2b combined with PD-1 inhibitor and targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known to have had active malignancies other than HCC within the past 5 years or concurrently.
• 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.
• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital, Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

Related Links

• Related Info

Central Study Contacts

Chen chao, Associate Chief Physician

CONTACT

15950579776; njjloncologycc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: August 18, 2026
• Study Start: December 26, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)