NCT04943679

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-06-29
• Last updated: 2022-03-31

Locations

1 site across 1 country: China