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Checkpoint Inhibitor
Atezolizumab + Multi-Kinase Inhibitor for Liver Cancer
Phase 2
Recruiting
Led By Wen Wee Ma
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 2 x ULN or creatinine clearance >= 30 mL/min (calculated using the Cockcroft-Gault formula)
Hepatocellular carcinoma (HCC) confirmed by histological/cytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing whether atezolizumab, when given with either cabozantinib or lenvatinib, is more effective in treating liver cancer than either of those drugs given alone.
Who is the study for?
This trial is for adults with advanced liver cancer that's inoperable, locally advanced, or metastatic and have previously been treated. Participants must be able to take oral meds, have a specific performance status (ECOG 0 or 1), and their liver function needs to meet certain criteria. Women of childbearing age must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The study tests atezolizumab combined with cabozantinib or lenvatinib against just the multi-kinase inhibitors alone. Atezolizumab is an immunotherapy drug while cabozantinib and lenvatinib block enzymes that help tumor cells grow. The goal is to see if combining these treatments works better for treating liver cancer.See study design
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in various organs, fatigue, digestive issues such as nausea or diarrhea, abnormal blood counts leading to increased infection risk or bleeding problems, possible skin reactions, and potential impact on liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is within the required range.
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My liver cancer diagnosis follows specific medical guidelines.
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My condition cannot be cured with surgery or other treatments.
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I am 18 years old or older.
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My white blood cell count is healthy without needing medication to boost it.
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My liver function is mildly affected.
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I am fully active or have some restrictions but can still care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Progression-free survival (PFS)
Secondary outcome measures
Duration of response
Incidence of adverse events (AEs)
Objective response rate (ORR)
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (atezolizumab, cabozantinib or lenvatinib)Experimental Treatment3 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (cabozantinib or lenvatinib)Active Control2 Interventions
Patients receive cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cabozantinib
2020
Completed Phase 2
~1080
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,014 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,011 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,021 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine levels, is within the required range.I don't have any health issues that prevent me from taking new medications.I have been diagnosed with a specific type of liver cancer.I have not had a live vaccine within 4 weeks before, and won't need one during or within 5 months after atezolizumab treatment.I haven't had major surgery, minor surgery, cancer treatment, radiation, or experimental therapy within the last month.I have a history of specific lung conditions not caused by known factors.I am currently receiving treatment that boosts my immune system.My liver cancer diagnosis follows specific medical guidelines.My condition cannot be cured with surgery or other treatments.I am willing to go back to the study site for follow-up visits.I have active tuberculosis.I agree to use two forms of birth control while on the study drug and for 5 months after.I have or had an autoimmune disease or immune deficiency.I have signed the consent form for this trial within the last 28 days.I have previously been treated with immune therapy.I am 18 years old or older.I am currently taking medication that suppresses my immune system.My cancer progressed after first-line treatment with atezolizumab and bevacizumab.I can take pills by mouth.My white blood cell count is healthy without needing medication to boost it.My side effects from previous treatments are mild, except for hair loss and numbness.During the study, you must agree to visit the study center for check-ups and follow-up exams.My liver function is mildly affected.I have received multi-kinase inhibitor treatment for advanced disease.I have untreated or partially treated varices in my esophagus or stomach that are at high risk of bleeding.I am seeking treatment for the second time.My cancer has spread to my brain or its coverings.I am fully active or have some restrictions but can still care for myself.You are willing to come back to the hospital for check-ups during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (atezolizumab, cabozantinib or lenvatinib)
- Group 2: Arm B (cabozantinib or lenvatinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted for this research project?
"From the information available on clinicaltrials.gov, it appears that this trial is still recruiting patients. The first posting was on 5/27/2022 and the most recent update was on 10/18/2022."
Answered by AI
Are there other examples in the medical literature of Atezolizumab's effectiveness?
"Atezolizumab was first studied in 2008 and, to date, there have been a total of 186 completed studies. There are presently 603 live clinical trials with many taking place in Urbana, Illinois."
Answered by AI
Which patients does Atezolizumab help the most?
"Atezolizumab, typically used to treat cancer with immunotherapy, can also be effective for small cell lung cancer (sclc), malignant neoplasms, and other conditions where anti-vegf has been previously administered."
Answered by AI
Has this type of treatment been attempted before?
"Atezolizumab has been the focus of 603 clinical trials since 2008, with the first one sponsored by Hoffmann-La Roche. The study completed Phase 2 drug approval and enrolled 720 participants. In the years since, 186 more trials have taken place across 2504 cities in 75 countries."
Answered by AI
How many total subjects are enrolled in this clinical trial?
"To move forward, this study requires 122 consenting patients that meet the pre-defined inclusion criteria. Patients can participate from different locations such as Carle Cancer Center NCI Community Oncology Research Program in Urbana, Illinois and Mayo Clinic in Arizona in Scottsdale, Arizona."
Answered by AI
What is the Atezolizumab drug's official standing with the FDA?
"Atezolizumab is still being tested for efficacy in Phase 2 trials, so it only received a safety score of 2."
Answered by AI
In how many different medical clinics is this medical study being run today?
"The Carle Cancer Center NCI Community Oncology Research Program in Urbana, Mayo Clinic in Arizona in Scottsdale, Duke University Medical Center in Durham are three of the 12 recruiting sites for this clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
18 - 65
What site did they apply to?
University of Chicago Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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