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Monoclonal Antibodies

Atezolizumab for Liver Cancer

Phase 2

Waitlist Available

Led By Adel Kardosh, M.D., Ph.D.

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study intervention to date of death (any cause), assessed up to 24 months from start of study intervention

Awards & highlights

Study Summary

This trial is testing whether a combination of two cancer treatments can shrink tumors in patients with liver cancer who can't have surgery or who have cancer that has spread.

Eligible Conditions

Liver Cancer
Hepatocellular Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study intervention to date of death (any cause), assessed up to 24 months from start of study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study intervention to date of death (any cause), assessed up to 24 months from start of study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study intervention to date of death (any cause), assessed up to 24 months from start of study intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of progression-free participants

Secondary outcome measures

Disease control rate (DCR)

Incidence of grade >= 3 adverse events

Objective response rate (ORR)

+3 more

Other outcome measures

Descriptive summary of tumor and tumor immune cell populations

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (atezolizumab, Y-90, cabozantinib)Experimental Treatment4 Interventions

CYCLE 1: Patients receive atezolizumab IV over 60 minutes on day 1. Within 14 days, patients receive Y-90 intra-arterially. CYCLES 2+: Patients receive atezolizumab IV over 60 minutes on day 1 and cabozantinib PO QD on days 1-21. Treatment repeats every 21 days for a total of 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit may continue receiving atezolizumab and cabozantinib beyond cycle 12 at the discretion of the PI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

FDA approved

Biopsy

2014

Completed Phase 4

~1090

Atezolizumab

FDA approved

Yttrium Y 90 Glass Microspheres

2016

Completed Phase 2

~370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,726 Total Patients Enrolled

1 Trials studying Liver Cancer

339 Patients Enrolled for Liver Cancer

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

7,385,812 Total Patients Enrolled

1 Trials studying Liver Cancer

339 Patients Enrolled for Liver Cancer

Adel Kardosh, M.D., Ph.D.Principal InvestigatorOHSU Knight Cancer Institute

Frequently Asked Questions

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

Are there any new participants being accepted into the trial at this time?

"Unfortunately, this particular clinical trial is not enrolling patients at the moment. However, there are 2685 other studies that are still recruiting patients."

Answered by AI

Has Atezolizumab received approval from the Federal Drug Administration?

"Atezolizumab is a medication that, according to our team's assessment, rates a 2 in terms of safety. This is because it is only in Phase 2 trials meaning while there is some evidence supporting its safety, there is no data affirming its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Yttrium Y 90 Glass Microspheres, Atezolizumab, and Cabozantinib for the Treatment of Unresectable or Locally Advanced Hepatocellular Carcinoma

Adel Kardosh M.D., Ph.D. 2022. "Yttrium Y 90 Glass Microspheres, Atezolizumab, and Cabozantinib for the Treatment of Unresectable or Locally Advanced Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327738.