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 range18 Years
SexALL
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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.
✕. Any GI or pulmonary risks of bleeding.
✕. History of HIV Infection.
✕. Active co-infection with hepatitis B and hepatitis C.
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