UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy to combine radiofrequency ablation therapy and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Title of the study (Brief title)	Efficacy of RFA/hepatic arterial infusion of DDP-H combination in HCC
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Cases with hepatocellular carcinoma (HCC), for which radiofrequency ablation therapy (RFA) is a proper therapeutic indication, are prospectively divided into two groups in random fashion; 1) RFA alone, and 2) RFA and intrahepatic arterial infusion of DDP-H. The efficacy of DDP-H is evaluated based on the time to development of intrahepatic metastasis and overall survival.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	1) Primary endpoint, the time when a classical HCC is confirmed by several imaging modalities in the liver except for the vicinity to the RFA area. 2) Secondary endpoint, allover survival
Key secondary outcomes	Tumor markers of AFP, DCP and other serum biochemistries.

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 not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Radiofrequency ablation therapy
Interventions/Control_2	Radiofrequency ablation therapy + intrahepatic arterial 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	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) No residue of classical HCC after RFA 2) Japan integrated stage scores 2 or 3 3) Child-Pugh A or B 4) No active cancers except for HCC 5) Performance status (ECOG) 0, 1 or 2 6) Satisfying following serum biochemistries before therapy WBC 3,000 /micro litter=< Platelet 50,000 /micro litter=< Hb 8.0 g/dl=< Total bilirubin 3.0 g/dl=> Creatinine clearance 50ml/min=< (after adjustment to 1.73m2 of body surface area) 7) No anti-cancer treatments affecting the liver except for the RFA target 8) Agreement to be enrolled in a form of informed consent
Key exclusion criteria	1) Severe allergic history for iodine and platinum drug 2) Pregnant, possibility of pregnancy, or feeding a baby 3) Vascular involvement Vp3, Vv3 or more 4) Under interferon therapy 5) Other factors that a responsible doctor judged to be unsuitable
Target sample size	120

Research contact person
Name of lead principal investigator	Takeshi Suda
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Gastroenterology & Hepatology
Address	1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL	025-223-6161
Email	tspitt@med.niigata-u.ac.jp

Public contact
Name of contact person	Akihiko Ohsaki
Organization	Niigata Hepatocellular Carcinoma Therapy Study Group
Division name	Excutive office
Address	1-757 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL	025-227-2207
Homepage URL
Email	tm98020ao-nii@umin.ac.jp

Sponsor
Institute	Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 09 Month 01 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2014 Year 08 Month 01 Day
Date of closure to data entry	2015 Year 03 Month 01 Day
Date trial data considered complete	2015 Year 03 Month 01 Day
Date analysis concluded	2016 Year 03 Month 01 Day

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

Management information
Registered date	2009 Year 09 Month 01 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=R000002855