An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progressio
- Conditions
- advanced hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000005818
- Lead Sponsor
- Sapporo Medical University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1)History of use of sorafenib or another molecular-targeted drug 2)History of systemic chemotherapy 3)Clinically significant ascites (i.e., refractory ascites requiring drainage) 4)History of liver transplantation 5)Esophageal varices with the potential to bleed 6)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder 7)Concurrent or prior hepatic encephalopathy 8)Brain tumor 9)Currently on dialysis 10)Gastrointestinal hemorrhage during the previous month 11)Active double cancer 12)Currently treated with a CYP3A4 inducer (e.g., rifampicin) 13)Serious coexisting disease (NCI CTCAE grade 2 or higher arrhythmia and poorly controlled hypertension) 14)History of hypersensitivity to any component of the study drug 15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to) 16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease 17)Pregnant or nursing 18)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety after documentation of the first PD
- Secondary Outcome Measures
Name Time Method