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. - Randomised Phase II study of New FP therapy versus sorafenib in advanced HCC

ational Hospital Organization Kyushu Cancer Center Department of Hepato-biliary-pancreatology0 sites120 target enrollmentNovember 1, 2016

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: advanced hepatocellular carcinoma
Sponsor: ational Hospital Organization Kyushu Cancer Center Department of Hepato-biliary-pancreatology
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 1, 2016

End Date

May 1, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ational Hospital Organization Kyushu Cancer Center Department of Hepato-biliary-pancreatology

•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.