Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (HCC).
Full description
As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for the treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is also expected to be effective against HCC. However, because most HCC patients have accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of liver function impairment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age 20-74
- PS 0-2
- Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy
- Chid-Pugh A or B
- At least one measurable lesion by RECIST criteria
Exclusion criteria
- Large amount of pleural effusion or ascites
- Esophageal varices
- Simultaneously active double cancer
Trial design
Primary purpose
Allocation
Interventional model
Masking
35 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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