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

March 28, 2022 updated by: Shanghai Zhongshan Hospital

Phase I/II Study of Anti-PD-1/PD-L1 Antibodies Combined With Pegylated Interferon Alfa-2b in Patients With Advanced-Stage Hepatocellular Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced HCC patients who received the combination therapy with Anti-PD-1/PD-L1 Antibodies Plus Pegylated Interferon Alfa-2b Treatment

Description

Inclusion Criteria:

  1. ≥18 years old, male or female
  2. 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
  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 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.

Exclusion Criteria:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anti-PD-1/PD-L1 antibodies and Pegylated Interferon Alfa-2b
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
Drug: Anti-PD-1/PD-L1
Intravenous injection for up to 2 years
Drug: PEG-Interferon Alfa
3 µg/kg every week by subcutaneous injection for up to 2 years
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 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.
Up to 30 days after last treatment dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
Time Frame: 2 years
Evaluated by researchers based on the RECIST 1.1 standard
2 years
Progression free survival(PFS) [ Time Frame: 2 years ]
Time Frame: 2 years
Evaluated by researchers based on the RECIST 1.1 standard
2 years
To the relief time (TOR)
Time Frame: 2 years
Evaluated by researchers based on the RECIST 1.1 standard
2 years
Duration of relief(DOR)
Time Frame: 2 years
Evaluated by researchers based on the RECIST 1.1 standard
2 years
Disease Control Rate (DCR)
Time Frame: 2 years
Evaluated by researchers based on the RECIST 1.1 standard
2 years
9-month survival rate
Time Frame: 9-month
Evaluated by researchers based on the RECIST 1.1 standard
9-month
12-month survival rate
Time Frame: 12-month
Evaluated by researchers based on the RECIST 1.1 standard
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Yang Xu, M.D.&Ph.D, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B20210618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Anti-PD-1/PD-L1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe