Anti-PD-1/PD-L1 Antibodies Plus Pegylated Interferon Alfa-2b Treatment in Patients With Advanced-Stage HCC

Last updated: March 28, 2022
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Liver Cancer

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT04943679
B20210618
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years old, male or female
  2. Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosedclinically or pathologically, at least one measurable lesion without local treatment,Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. Patient has given written informed consent.
  5. The function of important organs meets the requirements
  6. Expected survival ≥12 weeks
  7. Non-surgical sterilization or women of childbearing age need to use amedically-accepted contraceptive (such as an intrauterine device, contraceptive orcondom) during the study period and within 3 months after the end of the studytreatment period.

Exclusion

Exclusion Criteria:

1.The patient has any active autoimmune disease or a history of autoimmune disease (such asthe 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 withoutany intervention after adulthood; asthma patients who require bronchodilators for medicalintervention cannot be included); 2.The patient is using immunosuppressive agents orsystemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg /day of prednisone or other therapeutic hormones), and continue to use within 2 weeks beforeenrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significantclinically significant bleeding symptoms or a clear bleeding tendency within 3 months priorto 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 resultsof 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 seriouslaboratory abnormalities.,with family or social factors, it will affect the safety ofpatients.

7.Liver tumor burden greater than 50% of the total liver volume, or patients who havepreviously undergone liver transplantation;Known for a history of central nervous systemmetastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonalantibodies;

Study Design

Total Participants: 15
Study Start date:
June 15, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, 200032
    China

    Active - Recruiting

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