Evaluation of the safety and efficacy of sorafenib therapy after TACE for unresectable hepatocellular carcinoma (multicenter study)
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000006475
- Lead Sponsor
- Kagoshima University Medical and Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Not provided
1) Patients previously treated with sorafenib or other molecular-targeting therapy 2) Patients previously treated with systemic chemotherapy 3) Patients with clinically significant ascites (refractory ascites requiring paracentesis) 4) Patients with extra-hepatic metastases at the time of the index TACE (Chest CT must be performed for confirmation.) 5) Patients with vascular invasion of Vp3/4 and Vv2/3 at the time of the index TACE 6) Patients with diffuse lesions at the time of the index TACE 7) Patients with a history of liver transplant 8) Patients with potential bleeding from esophageal varices 9) Patients who experienced any of the following within 12 months prior to enrollment in this study 10) Patients with a current or past history of hepatic encephalopathy 11) Patients with a brain tumor 12) Patients undergoing dialysis 13) Patients who had gastrointestinal hemorrhage within the past month 14) Patients with multiple active cancers 15) Patients receiving CYP3A4 inducers (e.g., rifampicin) 16) Patients with serious comorbidities (NCI-CTCAE Ver. 4 Grade 2 or greater arrhythmia, uncontrolled hypertension) 17) Patients with a history of serious hypersensitivity to sorafenib 18) Patients taking oral herbal medicine approved for the treatment of cancer (e.g., Shosaikoto) 19) Patients with disorders related to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) 20) Pregnant or breastfeeding patients 21) Other patients judged by the principal investigator or a co-investigator to be inappropriate to participate in this stud
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression
- Secondary Outcome Measures
Name Time Method