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Nivolumab + deb-TACE for Liver Cancer
Study Summary
This trial is testing whether adding the immunotherapy drug nivolumab to the standard liver cancer treatment deb-TACE improves outcomes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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- My liver, kidneys, and bone marrow are functioning well.I cannot undergo angiography/embolization due to medical reasons.You have had a serious allergic reaction to contrast dye in the past, even with medication to prevent it.My cancer has spread beyond the liver.I have had cancer before, but it was either skin cancer removed by surgery, treated cervical cancer, or another cancer that is not active and won't affect my liver cancer treatment.I am a man, sexually active with a woman capable of becoming pregnant, and will use highly effective contraception during and for 7 months after the study.My liver cancer cannot be cured with surgery, but it can be treated with a specific procedure.My liver cancer diagnosis is confirmed by my hospital's tests or I'm scheduled for a biopsy.I have had a liver transplant or part of my liver removed.I am not on high doses of steroids or other immune-weakening drugs.I am fully active or can carry out light work.My liver functions well enough for treatment, even if I'm on blood thinners.My kidney function is within the required range.My hepatitis B virus levels are low due to antiviral treatment.I have hepatitis C but am not currently being treated for it.I have an autoimmune disease but it's under control or doesn't require systemic treatment.I am using reliable birth control during and for 5 months after the study.My liver function is mildly affected.I am 18 years old or older.I've had treatments like embolization or ablation but my cancer has grown or spread.I have been treated with drugs that target the immune system.I am not able to have children due to menopause or surgery.
- Group 1: Cohort 2, deb-TACE + Nivolumab
- Group 2: Cohort 3, deb-TACE + Nivolumab
- Group 3: Cohort 1, deb-TACE + Nivolumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this medical research currently seeking participants?
"At present, this trial is not searching for participants. The research was initially posted on April 28th 2017 and the last update occurred on September 27th 2022. If you are looking into other clinical trials, there are 251 studies recruiting patients with liver neoplasms and a further 717 investigations enrolling subjects in Drug Eluting Bead Transarterial Chemoembolization treatments."
What precedent has been set for Drug Eluting Bead Transarterial Chemoembolization research?
"Presently, there are 717 studies underway examining the efficacy of Drug Eluting Bead Transarterial Chemoembolization. Of those, 82 have progressed to Phase 3 trials. The bulk of these investigations take place in Basel, BE; however, a total of 40291 sites across the world are running tests for this particular therapy."
How many volunteers are taking part in this clinical experiment?
"At this current juncture, no individuals are being sought for enrolment. This trial was initially posted on April 28th 2017 and last modified on September 27th 2022. If you're searching for other trials, there exist 251 studies requiring participants with liver neoplasms and 717 studies in need of candidates to undergo Drug Eluting Bead Transarterial Chemoembolization treatment."
In what scenarios is Drug Eluting Bead Transarterial Chemoembolization utilized?
"Drug Eluting Bead Transarterial Chemoembolization is shown to efficiently treat malignant neoplasms, such as unresectable melanoma and squamous cell carcinoma."
In what geographic areas is the experiment taking place?
"Nine sites are enrolling patients in this clinical trial. These include Memorial Sloan Kettering Cancer Commack located in Commack, Washington University School of Medicine situated in Saint Louis, and Memorial Sloan Kettering at Basking Ridge based out of Basking Ridge; amongst various other locations."
Is this experiment the first of its genre?
"Presently, there are 717 ongoing scientific studies that explore Drug Eluting Bead Transarterial Chemoembolization in cities and countries around the globe. This research effort was first initiated by Ono Pharmaceutical Co. Ltd back in 2012 which included 659 participants and trudged through both Phase 1 & 2 of drug approval before concluding. In total, 253 trials have been finalized since then."
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