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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
On the basis of conventional treatment, combined with Peg IFNα-2b
Jinling Hospital, Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGOne-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 year
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.
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.
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, Week 12, Week 24, Week 48, and Week 96.
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