Anti-PD-1/PD-L1 Antibodies Plus Pegylated Interferon Alfa-2b Treatment in Patients With Advanced-Stage HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: Anti-PD-1/PD-L1Drug: PEG-Interferon Alfa
- Registration Number
- NCT04943679
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- ≥18 years old, male or female
- Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Patient has given written informed consent.
- The function of important organs meets the requirements
- Expected survival ≥12 weeks
- Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.
1.The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2.The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization 5.Arterial/venous thrombosis in the first 6 months of randomization 6.According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.，with family or social factors, it will affect the safety of patients.
7.Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anti-PD-1/PD-L1 antibodies and Pegylated Interferon Alfa-2b Anti-PD-1/PD-L1 Peginterferon alfa-2b: 3 µg/kg every week by subcutaneous injection for up to 2 years; Anti-PD-1/PD-L1 Antibodies: given by intravenous injection at indicated dose for up to 2 years Anti-PD-1/PD-L1 antibodies and Pegylated Interferon Alfa-2b PEG-Interferon Alfa Peginterferon alfa-2b: 3 µg/kg every week by subcutaneous injection for up to 2 years; Anti-PD-1/PD-L1 Antibodies: given by intravenous injection at indicated dose for up to 2 years
- Primary Outcome Measures
Name Time Method Incidence of adverse events Up to 30 days after last treatment dose 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.
- Secondary Outcome Measures
Name Time Method Objective response rate(ORR) 2 years Evaluated by researchers based on the RECIST 1.1 standard
Progression free survival(PFS) [ Time Frame: 2 years ] 2 years Evaluated by researchers based on the RECIST 1.1 standard
To the relief time (TOR) 2 years Evaluated by researchers based on the RECIST 1.1 standard
Duration of relief(DOR) 2 years Evaluated by researchers based on the RECIST 1.1 standard
Disease Control Rate (DCR) 2 years Evaluated by researchers based on the RECIST 1.1 standard
9-month survival rate 9-month Evaluated by researchers based on the RECIST 1.1 standard
12-month survival rate 12-month Evaluated by researchers based on the RECIST 1.1 standard
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, China