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.

Study Overview

• Status: Recruiting
• Conditions: HBV-HCC; Unresectable Advanced HBV-related Liver Cancer
• Intervention / Treatment: Biological: Combined Peg IFNα-2b treatment group

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen chao, Associate Chief Physician; Phone Number: 15950579776; Email: njjloncologycc@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peg IFNα-2b combined with PD-1 inhibitor and targeted therapy	Biological: Combined Peg IFNα-2b treatment group; On the basis of conventional treatment, combined with Peg IFNα-2b

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	The best overall response, defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. Confirmed response requires tumor shrinkage to be confirmed at least 4 weeks after the initial documentation of response.	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	The change from baseline in HBsAg level, including the magnitude of decrease, kinetics, the rate of negativity (<0.05 IU/mL), and the rate of seroconversion.	At baseline, Week 12, Week 24, Week 36, Week 48, and Week 96
Disease Control Rate (DCR)	The best overall response, defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). For patients with SD, the response must be confirmed at least 12 weeks after the first dose of treatment.	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)	To evaluate HBV DNA levels, the magnitude of decrease from baseline, and the 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)	To evaluate HBeAg levels, the 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.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score from Baseline	To evaluate the change in ECOG Performance Status Score from baseline.	At baseline, Week 12, Week 24, Week 48, and Week 96.

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Peg IFNα-2b treat for HBV-HCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No