Improving Response to Immunotherapy in Patients with Advanced Liver Cancer and Chronic Hepatitis C Using Antiviral Therapy
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05717400
This study is exploring whether combining immune therapy and antiviral drugs can better control advanced liver cancer and chronic hepatitis C infection. The trial aims to see if this approach can improve treatment outcomes for patients.
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Program Overview
The purpose of this study is to find out if using immune therapy drugs like atezolizumab and bevacizumab, along with antiviral drugs for hepatitis C, can help manage advanced liver cancer and hepatitis C infection. Researchers want to see if this combination can improve the body's immune response and control the diseases more effectively.
Description
The main goals of this study are to:
- Measure how well the immune therapy and antiviral drugs work together to reduce liver cancer and clear hepatitis C infection.
- Observe changes in immune cells before and after antiviral treatment in patients with liver cancer and hepatitis C.
The study will also collect information on the safety of the treatment and track how long patients live without the disease getting worse.
Participants will need to meet certain health criteria and agree to follow the study procedures, including regular health checks and providing consent to participate.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older and able to provide consent.
- Have a confirmed diagnosis of advanced liver cancer that cannot be treated with surgery.
- Have not received previous systemic therapy for liver cancer.
- Have a detectable hepatitis C virus (HCV) infection.
- Have a specific liver function score (Child-Pugh A) and meet certain liver disease criteria.
- Have a life expectancy of more than 3 months.
- Have measurable cancer based on specific imaging criteria.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Men must agree to use contraception during the study and for 120 days after the last treatment.
- Have adequate organ function based on specific blood tests.
Exclusion Criteria
- Currently participating in another clinical trial or have used an investigational drug recently.
- Have had recent bleeding from esophageal or gastric varices.
- Have severe liver disease or other untreated liver conditions.
- Have had a solid organ or blood cell transplant.
- Have active autoimmune disease requiring treatment.
- Have a history of severe lung inflammation or current lung issues.
- Have active infections requiring treatment.
- Have psychiatric or substance abuse disorders that interfere with study participation.
- Are pregnant or breastfeeding.
- Have received certain immune therapies or have severe allergies to them.
- Have a history of HIV or active tuberculosis.
- Have received a live vaccine recently.
- Have untreated active hepatitis B infection.
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