A multicenter, phase Ib/II, open-label study of tivozanib with durvalumab in advanced hepatocellular carcinoma (DEDUCTIVE).
Sharmeen MahmoodDaneng LiArielle LeeJulie RoweMuhammed BegVijay KasturiRenuka IyerThomas AbramsFarshid DayyaniPublished in: Future oncology (London, England) (2023)
Durvalumab, a PD-L1 inhibitor, is part of an immunotherapeutic drug class shown to have prolonged survival benefit in patients with advanced stage hepatocellular carcinoma (HCC). Tivozanib is a potent and selective VEGFR 1, 2 and 3 tyrosine kinase inhibitor. While these medications have both demonstrated single-agent activity in HCC and have been combined safely with other therapies, there is no data on their concurrent therapeutic effects. In the phase Ib DEDUCTIVE trial, the combination of tivozanib plus durvalumab is evaluated for safety and tolerability. Here, the design of and rationale for this trial in both treatment naive patients and those who progress on atezolizumab and bevacizumab for advanced or metastatic HCC are described. Clinical Trial Registration: NCT03970616.
Keyphrases
- clinical trial
- open label
- phase ii
- phase iii
- study protocol
- double blind
- end stage renal disease
- newly diagnosed
- ejection fraction
- squamous cell carcinoma
- chronic kidney disease
- small cell lung cancer
- peritoneal dialysis
- phase ii study
- emergency department
- deep learning
- locally advanced
- artificial intelligence
- drug induced
- anti inflammatory
- endothelial cells
- machine learning
- smoking cessation