UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transcatheter arterial infusion chemotherapy using miriplatin in patients with advanced hepatocellular carcinoma: Prospective randomized study, Lip-TAI vs. Lip+DSM-TAI
Title of the study (Brief title)	TAI using miriplatin: Lip-TAI vs. Lip+DSM-TAI
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficacy of lipiodol+degradable starch microspheres (DSM)-transarterial infusion chemotherapy (TAI) using miriplatin for advanced HCC in a randomized trial between lipiodol-TAI and lipiodol+DSM-TAI.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time-to-progression
Key secondary outcomes	Tumor response, overall survival, and safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lipiodol-TAI using miriplatin The injection of Lipiodol was limited to 6 mL.
Interventions/Control_2	Lipiodol+DSM-TAI After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of Lipiodol was limited to 6 mL.
Interventions/Control_3	Lipiodol-TAI using miriplatin The injection of Lipiodol was limited to 10 mL.
Interventions/Control_4	Lipiodol+DSM-TAI After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of Lipiodol was limited to 10 mL.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically proven or clinically diagnosed hepatocellular carcinoma. 2) Locally nodular disease without extrahepatic metastasis. 3) No indication for surgical resection and local ablation. 4) No vascular tumor thrombosis (portal vein, hepatic vein, and bile duct). 5) Not remarkable findings of A-V shunt and/or A-P shunt. 6) The emulsion of miriplatin and Lipiodol<= 6 mL: The maximum tumor diameter <= 5 cm and the tumor number <= 5 nodules in the liver. The emulusion of miriplatin and lipiodol > 6 mL: The maxmum tumor diameter <= 10 cm and the tumor number <= 10 nodules in the liver. 7) Do not have effect of pervious treatment. 8) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9) Child-Pugh score of A or B. 10) Adequate organ and marrow function listed below. (1) leukocyte count >= 3000/mm3 (2) platelet count >= 50000/mm3 (3) hemoglobin level >= 9.5 g/dL (4) total bilirubin <= 3.0 mg/dL (5) serum albumin 2.5-3.5 g/dL (6) serum creatinine level normal upper level (7) BUN <= 25 mg/dL 11) Age >= 20 years old 12) Life expectancy at least 3 months.
Key exclusion criteria	1) Parients with severe complicating disease except chronic hepatitis or liver cirrhosis. 2) Patients with active double cancer. 3) The patient with the anamnesis of the hypersensitivity. 4) A pregnant woman, or woman who may pregnant and who are nursing. 5) Patients who were disqualified by doctor in attendance.
Target sample size	100

Research contact person
Name of lead principal investigator	Takahiro Yamasaki
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 10 Month 07 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 09 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005404