UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of efficacy, safety and pharmacokinetics of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.
Title of the study (Brief title)	Study for evaluating efficacy, safety and pharmacokinetics of TACE with miriplatin in the treatment of patients with HCC.
Region	Japan

Condition
Condition	Hepatocellular carcinoma (HCC)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety, efficacy and pharmacokinetics of TACE with miriplatin for HCC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Tumor response (Treatment effect: TE)
Key secondary outcomes	Tumor marker change, overall survival, safety, pharmacokinetics (plasma Pt conc.)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TACE with miriplatin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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)Patients who were provided written informed consent. 2)Life expectancy of at least 12 weeks. 3)Histologically proven or clinically diagnosed hepatocellular carcinoma (dynamic CT/MRI). 4)No indication for surgical resection and local ablation. 5)Locally nodular disease without extrahepatic metastasis. Number of tumors are up to 5 (The maximum tumor diameter <= 5 cm). 6)Patients with no or one history of TACE therapy. 7)Performance status (ECOG) of 0-2 8)Child-Pugh class A or B. 9)Patients who fulfill of the inclusion criteria below. a) Hemoglobin >= 8.5 g/dl b) Neutrophil >=1,500 /mm3 c) PLT >= 50,000 /mm3 d) T.Bil <=3.0mg/dl e) ALT, AST <= within 6 times of normal limit f) Cre <= within 1.5 times of normal limit
Key exclusion criteria	1)History of malignant tumor 2)Serious and active infection, except for HBV and HCV 3)History of HIV infection 4)Renal dialysis 5)Diffuse tumor lesion 6)Extrahepatic metastasis 7)Vascular invasion 8)Intracranial tumor 9)Clinically uncontrolled ascites or pleural effusion 10)Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment 11)Esophageal and/or gastric varices which has high risk of bleeding 12)History of thrombosis and/or embolism within 6 months of the start of treatment 13)History of receiving any of the following therapies: a)Systemic chemotherapy for advanced HCC b)Local therapy within 3 months of the start of treatment c)Invasive surgery within 4 weeks of the start of treatment d)History of allogenic transplantation e)History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study 14)Concurrent disease or disability that may affect evaluation of the effects of the study drugs 15)Enrollment in another study within 4 weeks of study entry 16)Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant 17)Risk of allergic reactions to the study drugs 18)Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results 19)Any condition that could jeopardize the safety of the patient or their compliance in the study
Target sample size	20

Research contact person
Name of lead principal investigator	Keisuke Hino
Organization	Kawasaki Medical School
Division name	Department of Hepatology and Pancreatology
Address	577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL	086-462-1111
Email

Public contact
Name of contact person	Yasuyuki Tomiyama
Organization	Kawasaki Medical School
Division name	Department of Hepatology and Pancreatology
Address	577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email

Sponsor
Institute	Kawasaki Medical School
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	2011 Year 12 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 09 Month 15 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 21 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008183