UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 study of combination chemotherapy for hepatocellular carcinoma using Miripla (SM11355) and IA-call (DDP-H)
Title of the study (Brief title)	Combination chemotherapy of SM11355 and DDP-H for HCC
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This study aims to select candidate predictors for therapeutic efficacy of and to clarify the usefulness of combinatorial usage of SM11355 with intrahepatic arterial infusion of DDP-H in local managements of hepatocellular carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Tiem to progression
Key secondary outcomes	overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SM11355
Interventions/Control_2	SM11355 after intrahepatic infusion of DDP-H
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) Histologically and/or clinically proven hepatocellular carcinoma except for mixed type. 2) Local managements are difficult by surgical resection, puncture-based therapies, radiation therapy or transcatheter arterial chemoembolization. 3) No indication or consent for liver transplantation. 4) Indication for lipiodolization using SM11355 and intrahepatic arterial infusion of DDP-H. 5) No additional treatments will be performed targeting the lesions for SM11355. 6) In the area where SM11355 is going to be infused, there are target lesions larger than 10mm, which can be measured using CT and/or MRI. 7) Age over 20 years old. 8) ECOG performance status score of 0-2. 9) Sufficient functional reserve of major organs as indicated below. >Neutrophil count :1,500/mm3 =< >Platelet count :50,000/mm3 =< >Hemoglobin : 8.0 g/dL =< >Albumin : 3.0 g/dL =< >Total bilirubin : 3.0 mg/dL => >Total amylase in serum : 324 IU/bL => >Creatinine clearance : 50ml/min =< (adjusted for 1.73m2 of body surface area) 10) Child-Pugh score of equal or less than 8. 11) An interval of 4 or more weeks after any latest therapy against hepatocellular carcinoma. 12) A written informed consent from a patient himself/herself.
Key exclusion criteria	1) Pleural effusion and/or ascites refractory to treatments. 2) Comorbidity: >Active infectious diseases except for hepatitis. >Active bleeding from GI tract. >Active concomitant cancer with invasive nature. >Severe mental disorder or hepatic encephalopathy. 3) A history of severe allergic reaction against iodine contrast medium and/or platinum agents. 4) A pregnant or lactating female or female of childbearing age unless using effective contraception. 5) Ongoing interferon therapy. 6) Difficulties of oral intake. 7) Other serious conditions judged to be inadequate by a responsible doctor.
Target sample size	200

Research contact person
Name of lead principal investigator	Takeshi Suda
Organization	Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Division name	Department of Gastroenterology & Hepatology
Address	4132 Urasa, Minami-Uonuma, Niigata 949-7302, Japan
TEL	025(777)3200
Email	tspitt@med.niigata-u.ac.jp

Public contact
Name of contact person	Takeshi Suda
Organization	Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Division name	Department of Gastroenterology & Hepatology
Address	4132 Urasa, Minami-Uonuma, Niigata 949-7302, Japan
TEL	025(777)3200
Homepage URL
Email	tspitt@med.niigata-u.ac.jp

Sponsor
Institute	Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	1) Department of Gastroenterology and Hepatology, Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital 2) Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University 3) Department of Gastroenterology and Hepatology, Niigata City General Hospital

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 20 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2015 Year 12 Month 11 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete	2016 Year 08 Month 01 Day
Date analysis concluded	2016 Year 11 Month 01 Day

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

Management information
Registered date	2010 Year 12 Month 09 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005583