Randomized Controlled Trial Comparing Efficacy of Sorafenib versus Sorafenib In combination with Low dose cisplatin /fluorouracil hepatic arterial InfUSion chemotherapy in Patients with Advanced Hepatocellular Carcinoma(SILIUS Phase III) - SILIUS Phase III

SILIUS Trial Group,Japan Ministry of Health, Labour and Welfare0 sites190 target enrollmentOctober 4, 2010

ConditionsHCC

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HCC
Sponsor: SILIUS Trial Group,Japan Ministry of Health, Labour and Welfare
Enrollment: 190
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 4, 2010

End Date

September 1, 2013

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

SILIUS Trial Group,Japan Ministry of Health, Labour and Welfare

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) Previous malignancy 2\) Renal failure 3\) Any heart disease as follows a) Congestive heart failure defined as NYHA class III or IV b) Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening c) Serious cardiac arrhythmia d) Serious hypertension 4\) Active clinically serious infections except for HBV and HCV 5\) Active chicken pox. 6\) Auditory disorder. 7\) Known history of HIV infection. 8\) Known metastatic or meningeal tumors. 9\) Extrahepatic tumor spread which affects patient's prognosis 10\) History of seizure disorder. 11\) Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry. 12\) Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization. 13\) Any history of treatment as follows: a) Treatment with the agent which induces CYP3A4 b) Surgical procedure within 4 weeks prior to start of study drug c) History of organ allograft 14\) Patients unable to swallow oral medications. 15\) Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics. 16\) Medication that may affect to the absorption of drug or pharmacokinetics. 17\) Any disease or disorder that may affect the evaluation of study drug. 18\) Entry to the other clinical trial within 4 weeks prior to entry to this study. 19\) Pregnant or breast\-feeding patients. 20\) Known allergy to the investigational agent or any agent given in association with this trial. 21\) Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results. 22\) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.