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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Cabozantinib (40mg) will be taken by mouth daily for 8 weeks.
Nivolumab 240mg intravenously every 2 weeks (days 14, 28, 42, and 56 for a total of four doses), in combination with Cabozantinib 40mg by mouth daily for 8 weeks.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Number of adverse events in participants of neoadjuvant cabozantinib plus nivolumab.
Time frame: 4 years
Number of patients who complete pre-op treatment and proceed to surgery.
Time frame: 4 years
Percentage of participants who obtain R0 resection.
Time frame: 4 years
Percentage of participants who obtain a pathologic complete response (CR).
Time frame: 4 years
Percentage of participants who obtain a major pathologic responses (MPR)
Time frame: 4 years
Objective response rate (ORR)
Time frame: 4 years
Median Overall Survival (OS)
Time frame: 5 years
Disease free survival (DFS)
Time frame: 5 years
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