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Checkpoint Inhibitor
Atezolizumab +/− Bevacizumab for Liver Cancer (Kirros Trial)
Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease (at least one untreated target lesion) according to RECIST v1.1
ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at the safety and effectiveness of two drugs for treating advanced liver cancer in people with cirrhosis.
Who is the study for?
This trial is for adults with advanced liver cancer (HCC) that can't be removed by surgery and who have moderate to severe liver impairment (Child-Pugh B7 or B8). They should not have had previous systemic treatments for their cancer, must be able to perform daily activities with minimal assistance, and women must avoid pregnancy.
What is being tested?
The study is testing the safety and effectiveness of Atezolizumab alone or combined with Bevacizumab as a first-line treatment. Participants will receive these drugs to see if they help control liver cancer better than current treatments.
What are the potential side effects?
Atezolizumab may cause immune-related reactions, fatigue, nausea, and infections. Bevacizumab might lead to high blood pressure, bleeding issues, protein in urine, and could impact wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one cancer lesion that hasn't been treated yet.
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I have been active and mostly self-sufficient in the last week.
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My condition cannot be cured with surgery or local treatments.
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I haven't received any treatment for advanced liver cancer.
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My liver disease is moderately severe.
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I am willing to prevent pregnancy and not donate eggs during the trial.
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My liver cancer is advanced, can't be removed by surgery, and is confirmed by tests or clinical criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants with Adverse Events
Secondary study objectives
Change From Baseline in EORTC QLQ-C30 Scores
Change From Baseline in EORTC QLQ-HCC18 Scores
Change from baseline in PRO-CTCAE Scores
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: AtezolizumabExperimental Treatment1 Intervention
Participants will receive Atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Group II: Cohort A: Atezolizumab+BevacizumabExperimental Treatment2 Interventions
Participants will receive Atezolizumab plus Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5540
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,558 Previous Clinical Trials
569,316 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
896,247 Total Patients Enrolled
3 Trials studying Liver Cancer
126 Patients Enrolled for Liver Cancer
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