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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

Kirros Trial 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.Check my eligibility

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.See study design

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.

Kirros Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Kirros Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events

Secondary outcome measures

Change From Baseline in EORTC QLQ-C30 Scores

Change From Baseline in IL46 Scores

Change From Baseline in QLQ-HCC18 Scores

+5 more

Kirros 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

2017

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5280

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,541 Previous Clinical Trials

568,023 Total Patients Enrolled

4 Trials studying Liver Cancer

140 Patients Enrolled for Liver Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,820 Total Patients Enrolled

3 Trials studying Liver Cancer

126 Patients Enrolled for Liver Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants for this experiment?

"Affirmative. As per clinicaltrials.gov, this medical experiment — initially posted on November 22nd 2023 — is currently seeking participants. The trial needs 120 patients to be recruited from 1 site specifically."

Answered by AI

Are there currently opportunities for participants to enroll in this experiment?

"Affirmative. According to the records on clinicaltrials.gov, this medical trial is actively looking for participants. It was initially posted on November 22nd 2023 and most recently revised a few weeks later on November 10th 2023. This study requires 120 patients from 1 medical centre or hospital facility."

Answered by AI

What adverse impacts have been observed when administering Atezolizumab+Bevacizumab to Cohort A?

"Based on the evidence available, Power has assigned Cohort A: Atezolizumab+Bevacizumab a safety rating of 2 due to being in Phase 2 trials. This means that there is some supporting data for its safety but no proven efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

2024. "A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096779.

All > Liver Cancer > Hepatocellular Carcinoma