This study is being done to analyze the safety, tolerability, and efficacy of treatment using combination of Pegylated Interferon Alfa-2b and anti-PD-1/PD-L1 antibodies for patients with advanced hepatocellular carcinoma.
This is a study of combination anti-PD-1/PD-L1 antibodies and peginterferon alfa-2b for adult patients (≥18) with advanced hepatocellular carcinoma. Each 21 day dosing period will constitute a cycle. Pegylated Interferon Alfa-2b has been proven to prolong the survival of HCC patients. Pegylated Interferon Alfa-2b is given subcutaneously, weekly during each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal. Anti-PD-1/PD-L1 antibodies (including pembrolizumeb, nivolumab, sintilimab, toripalimab, camrelizumeb, tislelizumab and atezolizumab etc.) are given intravenously at assigned dose. Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal. This study is aimed to evaluate the safety and efficacy of the combination of Pegylated Interferon Alfa-2b and PD-1/PD-L1 mAb in unresectable late-stage HCC patients.
Study Type
OBSERVATIONAL
Enrollment
15
Intravenous injection for up to 2 years
3 µg/kg every week by subcutaneous injection for up to 2 years
Zhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGIncidence of adverse events
Safety will be monitored by addressing and recording all adverse events (AEs), serious adverse events (SAEs) and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Time frame: Up to 30 days after last treatment dose
Objective response rate(ORR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
Progression free survival(PFS) [ Time Frame: 2 years ]
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
To the relief time (TOR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
Duration of relief(DOR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
Disease Control Rate (DCR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
9-month survival rate
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 9-month
12-month survival rate
Evaluated by researchers based on the RECIST 1.1 standard
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Time frame: 12-month