Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
Phase 2
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000007265
- Lead Sponsor
- Gastroenterology, Department of Medicine Kitasato University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1) Receiving pimozide 2) With other sever diseases 3) Clinical suspicion or history of metastasis to brain or meninges 4) Patients who need anticonvulsants therapy 5) Ascites and/or pleural effusion to need treatment 6) Pyloric stenosis and/or intestinal obstruction 7) Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 8) History of drug allergy 9) Pregnant or lactating women or women of childbearing potential, and no birth-control 10) Patient who doesn't have ability or intention that cooperates for procedure of the study 11) Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Response Rate in overall phase(0-120 hours after chemotherapy)
- Secondary Outcome Measures
Name Time Method Complete Response Rate in acute and delayed phase Complete Control Rate in overall, acute and delayed phase The proportion of patients without nausea in overall, acute and delayed phase Safety