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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%
Pain in extremity
7%
Peripheral sensory neuropathy
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%
Musculoskeletal chest pain
1%
Respiratory tract infection
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
~1760
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
4,942 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,242 Total Patients Enrolled
105 Trials studying Liver Cancer
27,028 Patients Enrolled for Liver Cancer
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,909 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.
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