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Tyrosine Kinase Inhibitor
Cabozantinib + Immunotherapy + TACE for Liver Cancer
Phase 2
Recruiting
Led By Farshid Dayyani, MD, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ and marrow function as defined below: Leukocytes ≥ 2,000/mcL, absolute neutrophil count ≥ 1000/mcL, platelets ≥ 60,000/mcl, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present, creatinine <1.5ULN, hemoglobin ≥ 8 g/dL, Serum albumin ≥ 2.8 g/dL, Urine protein/creatinine ration (UPCR) ≤ 1 mg/mg
Not a candidate for resection or transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Awards & highlights
Study Summary
This trial is testing whether a drug called cabozantinib, used together with other drugs, can help people with HCC who are not candidates for curative treatment.
Who is the study for?
Adults with hepatocellular carcinoma (HCC) who can't have curative treatments like surgery or transplantation. They must be physically able to perform daily activities with minimal assistance, have a tumor treatable by TACE, good liver function (Child-Pugh A-B7), and adequate blood and organ function. Women of childbearing potential and men must use contraception during the trial.Check my eligibility
What is being tested?
The trial is testing the effectiveness of cabozantinib combined with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in treating HCC. It's an open-label study where all participants receive the same treatment without being compared to a control group.See study design
What are the potential side effects?
Possible side effects include high blood pressure, tiredness, loss of appetite, gastrointestinal symptoms like diarrhea or nausea, skin reactions at injection sites for immunotherapy drugs, potential liver toxicity from TACE procedure, and increased risk of infection due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood and organ tests meet the required levels for treatment.
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I cannot have surgery or a transplant for my condition.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have been diagnosed with liver cancer.
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I have a tumor that can be treated with TACE.
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My liver function is mildly to moderately impaired.
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I have at least one tumor that can be measured and has not been treated or has grown after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate
Percentage of Participants with Progression-free Survival at 6 Months
Secondary outcome measures
Conversion Rate to Resectable
Overall Survival of Patients who Received Cabozantinib with Ipilimumab/Nivolumab and TACE
Percentage of Grade 3-5 Adverse Events
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cabozantinib with Ipilimumab/Nivolumab and TACEExperimental Treatment4 Interventions
Subjects receive Cabozantinib 40 mg daily on days 1-28 of a 28 day cycle, this is to be started 7-14 days after the last TACE procedure.
Nivolumab 480 mg IV on day 1 of a 28 day cycle (cycle 2 and beyond), this is to be started 7-14 days after the last TACE procedure.
Nivolumab: 3mg/kg IV on day 1 of a 21 day cycle x 1 dose.
Ipilimumab: 1 mg/kg on day 1 of a 21 day cycle x 1 dose
TACE: Within 3-4 weeks of cycle 1 day 1; may be done up to 3 times (9-12 weeks total), the intervals between each TACE treatment can vary based on investigator's discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Cabozantinib
2020
Completed Phase 2
~1080
Transarterial Chemoembolization
2009
Completed Phase 1
~90
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,008 Total Patients Enrolled
2 Trials studying Hepatocellular Carcinoma
15 Patients Enrolled for Hepatocellular Carcinoma
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,516 Total Patients Enrolled
6 Trials studying Hepatocellular Carcinoma
4,471 Patients Enrolled for Hepatocellular Carcinoma
Farshid Dayyani, MD, PhD5.02 ReviewsPrincipal Investigator - Chao Family Comprehensive Cancer Center
University of California, Irvine
3 Previous Clinical Trials
62 Total Patients Enrolled
5Patient Review
Dr. Sayyani is very attuned to the needs of clinical trial patients. He's been great at adjusting my chemotherapeutic drugs to manage side effects. He's also very patient and open to questions, even if he can't answer everything.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot be taking any other experimental drugs.I have received treatments that travel through my bloodstream to reach cancer cells anywhere in my body.All my side effects from cancer treatment have improved, except for hair loss.I have healed from any major or minor surgeries before starting the study treatment.I am allergic to medications similar to nivolumab or cabozantinib.My blood and organ tests meet the required levels for treatment.I haven't had any cancer other than non-serious skin, early prostate, or treated cervical cancer in the last 3 years.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I am on certain blood thinners but not on high-risk ones, and my platelet count is good.I agree to use birth control or abstain from sex during and for 4 months after the study.I do not have any uncontrolled illnesses or recent major heart or blood vessel problems.I am using effective birth control while being treated with ipilimumab and will continue for 3 months after the last dose.I have not had any local treatments for liver cancer in the last 3 months.I can swallow pills.I do not have any serious wounds, thyroid issues, severe liver problems, or mental health/social situations that would stop me from following the study's requirements.I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.I have been treated with cabozantinib before.I have had or currently have lung inflammation treated with steroids.My cancer has spread outside of the liver.I cannot have surgery or a transplant for my condition.I have lung lesions or tumors inside my airways.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I can take care of myself but might not be able to do heavy physical work.I have not had significant bleeding in the last 3 months.My cancer affects major blood vessels but not those inside the liver.I haven't taken any kinase inhibitor medication in the last 2 weeks.I have been diagnosed with fibrolamellar hepatocellular carcinoma.I have not received a live vaccine in the last 30 days.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't needed strong medication for an autoimmune disease in the last 2 years.I am currently being treated for an infection.I have an active tuberculosis infection.I am 18 years old or older.I have been diagnosed with liver cancer.I have a tumor that can be treated with TACE.My liver function is mildly to moderately impaired.I have at least one tumor that can be measured and has not been treated or has grown after treatment.I am using effective birth control while receiving nivolumab and will continue for 5 months after the last dose.I am a woman who can still have children and have not been through menopause.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib with Ipilimumab/Nivolumab and TACE
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.
Has Transarterial Chemoembolization been validated by the Food and Drug Administration?
"Our team at Power assigned Transarterial Chemoembolization a score of 2, as this is an experimental Phase 2 trial with existing safety data but no proof yet that it's efficacious."
Answered by AI
How many participants are receiving treatment as part of this trial?
"Affirmative. Clinicaltrials.gov confirms that this research endeavor, which was first posted on August 7th 2020 is currently recruiting participants. There are 35 spots available at 1 medical centre for those interested in taking part."
Answered by AI
For which medical ailments is Transarterial Chemoembolization typically prescribed?
"Transarterial Chemoembolization is traditionally employed to treat inoperable melanoma cases. It can, however, also be deployed as a strategy against squamous cell carcinoma, and for those with a heightened risk of relapse or recurrent disease."
Answered by AI
What objectives does this research endeavor seek to accomplish?
"The primary goal of this analysis is to ascertain the Progression-free Survival rate at 6 months. Secondary objectives include examining Overall Survival, documenting Grade 3-5 Adverse Events according to CTCAE Version 5.0., and gauging Conversion Rate to Resectable according to Milan criteria (single tumors ≤5 cm in diameter or no more than three tumors ≤3 cm in diameter). Each patient will be monitored for a duration of roughly 1 year from their registration date until disease progression, toxicity, delay of treatment, or withdrawal of treatment occurs - whichever comes first."
Answered by AI
Could you elaborate on past research conducted involving Transarterial Chemoembolization?
"Currently, there are 94 Phase 3 studies of Transarterial Chemoembolization being conducted across 840 different locations. The majority of the sites for this research are located in Pittsburgh, Pennsylvania; however, clinical trials pertaining to Transarterial Chemoembolization can be found at 46020 centres worldwide."
Answered by AI
Is there still room for enrolment in this clinical experiment?
"Affirmative. According to the clinicaltrials.gov listing, this trial was initially posted on August 7th 2020 and is still open for participation today. 35 individuals are needed at a single location in order to complete the study's requirements."
Answered by AI
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