Peg IFNα-2b Therapy for Unresectable Mid to Late Stage HBV-HCC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Combined Peg IFNα-2b treatment group
Biological/VaccineOn the basis of conventional treatment, combined with Peg IFNα-2b
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Peg IFNα-2b combined with PD-1 inhibitor and targeted therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At 1 year2
Overall Survival (OS)
From first dose of treatment to date of death due to any cause, assessed up to 36 months.
Time frame
From first dose of treatment to date of death due to any cause, assessed up to 36 months.Secondary outcomes
1
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.
Time frame
At the time of best overall response, assessed up to 24 months.2
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.
Time frame
At baseline, Week 12, Week 24, Week 36, Week 48, and Week 963
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.
Time frame
From baseline until the end of treatment or disease progression, assessed up to 24 months.4
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.
Time frame
At baseline, Week 12, Week 24, Week 48, and Week 96.Sponsors and contacts
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Source ClinicalTrials.gov