NCT05717400

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if giving immune checkpoint therapy (such as atezolizumab) and bevacizumab to patients who have HCC and are receiving DAAs may help to control HCC and hepatitis C.

Detailed description

Primary Objective(s): * Estimate the objective response rate (ORR) to ICT and estimate the sustained virologic response (SVR) in patients with HCC and chronic HCV infection using HCV clearance with DAA therapy. * Estimate the change of the overall T cells and virus-specific T cells before and after the antiviral treatment in patients with HCC and chronic HCV infection using HCV clearance with DAA therapy. Secondary objective: --Collect the safety profile of the treatment and estimate the time-to-event variable such as overall survival (OS) and progression free survival (PFS).

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Given by vein (IV)
DRUG	Atezolizumab	Given by vein (IV)
DRUG	Sofosbuvir	Given by PO
DRUG	Velpatasvir	Given by PO
DRUG	Voxilaprevir	Given by PO
DRUG	Ribavirin	Given by PO

Timeline

• Start date: 2023-03-17
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2023-02-08
• Last updated: 2024-12-31
• Results posted: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study