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Clinical Trial Summary

The purpose of this clinical research study is to learn about the safety and effectiveness of cabozantinib and nivolumab in people with hepatocellular carcinoma (HCC).


Clinical Trial Description

Primary objective is to evaluate overall response rate Secondary objectives are to evaluate progression-free survival and overall survival Exploratory endpoints To explore the association between c-MET, PD-1/PD-L1 (and PD-L2) expression by immunohistochemistry, RNA seq genomic profiling and antitumor efficacy of nivolumab + cabozantinib based on RECIST 1.1 To evaluate correlation between fibrosis stage by histology, by magnetic resonance elastography (MRE) imaging and by IGF1 scores To evaluate baseline and longitudinal changes of blood and tumor markers such as TNFα, pSTAT3, and EGFR, immune cell density including frequency of PD-1 + 4-1BB + CD8+ T cells, pro-inflammatory cytokines, and hepatic fibrosis markers (APRI, FIB-4, hyaluronic acid, FibroTest [FibroSure], nonalcoholic fatty-liver disease fibrosis score, enhanced liver fibrosis [ELF]) test as biomarkers of response to therapy To evaluate candidate serum and tissue biomarkers to predict response to cabozantinib (e.g. Kallikrein 5, KLK-7, MCP-1, LAP/TGF-β1, Galectin-3) and nivolumab (e.g. angiogenin, Endostatin, PGI, PAI-1, Cystatin-B, CD8 T cell frequency and Ki67) To evaluate the predictive value of dynamic changes in fibrosis stage (defined by a minimum 2-point improvement in fibrosis grade 0-4 per MRE) and in IGF-1 blood scores ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05039736
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Sunyoung Lee
Phone 713-792-8501
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date February 28, 2022
Completion date June 30, 2023

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