Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Defini… (NCT03299946) | Clinical Trial Compass
CompletedPhase 1
Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)
United States15 participantsStarted 2018-05-14
Plain-language summary
The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must have locally advanced/borderline resectable hepatocellular carcinoma.
. Must have measurable disease.
. Age ≥18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
. Patients must have adequate liver remnant and function.
. Antiviral therapy per local standard of care for hepatitis B.
. Woman of child bearing potential must have a negative pregnancy test.
Exclusion criteria
. Fibrolamellar carcinoma or mixed HCC.
. Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
. Concomitant Anticoagulation therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse events in participants of neoadjuvant cabozantinib plus nivolumab.
Timeframe: 4 years
2
Number of patients who complete pre-op treatment and proceed to surgery.
Timeframe: 4 years
Trial details
NCT IDNCT03299946
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins