Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chroni… (NCT05717400) | Clinical Trial Compass
TerminatedPhase 4
Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy
Stopped: PI Request
United States2 participantsStarted 2023-03-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be willing and able to provide written informed consent for the trial.
✓. Be at least 18 years of age on the day of signing informed consent.
✓. Ability to comply with the study protocol, in the investigator's judgment
✓. Have histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) based on pathology report.
✓. Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
✓. No prior systemic therapy for HCC.
✓. Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1.
✓. ECOG Performance Status of 0 or 1
Exclusion criteria
✕. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
✕. Has had esophageal or gastric variceal bleeding within the last 6 months. All subjects will be screened for esophageal varices, unless such screening has been performed in the past 12 months before first dose of treatment. If varices are present, they should be treated according to institutional standards before starting study treatment.
✕. Subjects with alanine aminotransferase (ALT) \>5 × ULN at Day 1 are not eligible for enrollment.
✕. Subjects with Total Bilirubin (Tbil) \>2.0 mg/dL at Day 1 are not eligible for enrollment
✕. Subjects with clinically apparent ascites or encephalopathy, or untreated varices are not eligible for enrollment. Subjects with Child-Pugh class B and C liver disease are also ineligible.
✕. Portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging.
✕. Has had encephalopathy in the last 6 months. Subjects on rifaximin or lactulose to control their encephalopathy are not allowed.