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 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 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007265

Enrollment

Registered

2012-02-10

Start date

2011-11-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Palonosetron: day1 0.75mg (i.v.) Aprepitant: day1 125mg, 2-3 80mg (p.o.) Dexamethasone: day1 9.9mg (i.v.), 2-4 8mg (p.o.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are scheduled to receive hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma 2) No prior chemotherapy 3) Aged 20 years or older 4) Adequate organ function 5) ECOG performance status of 0 or 1 6) Written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Complete Response Rate in overall phase(0-120 hours after chemotherapy)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactHisashi Hidaka

Department of Medicine Kitasato University, School of Medicine Gastroenterology

hisashi7@kitasato-u.ac.jp042-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026