Randomised phase II study of Intra-arterial infusion therapy with cisplatin suspension in lipiodol and 5-fluorouracil(New FP therapy)versus sorafenib in advanced hepatocellular carcinoma.
- Conditions
- advanced hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000024661
- Lead Sponsor
- ational Hospital Organization Kyushu Cancer Center Department of Hepato-biliary-pancreatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
Patients will be excluded from the study if they meet any of the following criteria. 1) Having a history of molecular targeted drug or sorafenib. 2) Having a history of any previous systemic therapy. 3) Having clinically meaningful ascites that require a puncture method. 4) History of liver transplant. 5) Having esophageal varices that represent a high bleeding risk. 6) With cardiac infarction, unstable angina, cardiac failure and cerebral vascular disorder within 12 month before registration. 7) History of or current hepatic encephalopathy. 8) With cerebral tumors. 9) Having a dialysis. 10) With a gastrointestinal hemorrhage within 1 month before registration. 11) With a duplicate active cancer. 12) Taking drugs with CYP3A4 (Including rifampicin etc.) 13) Severe arrhythmia of CTCAE v4.0 >= grade 2 and uncontrolled high blood pressure defined in blood pressure guidelines 2014. 14) Having hypersensitivity reaction to any of the treatment components. 15) Taking approved crude drugs for cancer treatment. (Including shosaikoto.) 16) Known human immunodeficiency virus infection (HIV) or acquire immunodeficiency syndrome (AIDS) -related illness. 17) Pregnancy, nursing women. 18) Not eligible because of safety issues judged by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Responsive rate,AE, Down staging rate for Curative treatment