Unresectable hepatocellular carcinoma
Conditions
Interventions
None listed
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who provided written informed consent after receiving adequate explanation and demonstrating sufficient understanding, based on their own free will, to participate in this study 2. Patients aged 20 years or older at the time of consent acquisition 3. Patients with unresectable hepatocellular carcinoma 4. Patients with at least one measurable lesion (RECIST v1.1) 5. Patients with Child-Pugh classification A or B 6. Patients with an ECOG performance status (PS) of 2 or lower
Exclusion criteria
Exclusion criteria: 1. Patients receiving combination therapy with other anticancer agents 2. Patients with a history of systemic chemotherapy (using cytotoxic anticancer agents) 3. Patients with active concurrent cancer 4. Patients for whom administration of this drug is not recommended Patients with a history of severe hypersensitivity to any component of this drug Pregnant women or women who may become pregnant Patients with brain tumors Patients undergoing dialysis Patients with uncontrolled hypertension Patients who have been diagnosed with any of the following conditions within 12 months prior to registration Myocardial infarction, unstable angina, heart failure, cerebrovascular disorder Patients with esophageal varices at risk of bleeding Patients currently receiving CYP3A4 inducers (e.g., rifampicin) 5. Other patients deemed inappropriate by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between antitumor response by RECIST at 4 weeks after treatment and time to progression (TTP) | — |
Countries
Japan
Contacts
Public ContactTeiji Kuzuya
Fujita Health University Department of Gastroenterology and Hepatology
Outcome results
None listed