UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrograde isolated hepatic perfusion:Phase 1 trial
Title of the study (Brief title)	Phase 1 trial of R-IHP
Region	Japan

Condition
Condition	malignant liver neoplasm in advanced stage
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Performing Phase 1 study to establish therapeutic range of antineoplastic agents and evaluating the efficacy (antineoplastic effect, relief of symptoms, and overall survival rate) of Retrograde isolated hepatic perfusion for inoperatable malignant liver neoplasm
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Adverse effect within 4 weeks after the procedure 5-year survival rate
Key secondary outcomes	Assessment of the change in tumor burden 4 and 12 weeks after the procedure according to RECIST criteria

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Establish isolated hepatic circulation using balloon catheters. Perform the procedure twice, more than 4 weeks apart. Initial dose is cisplatin 35mg/m2 and gemcitabin 300mg/m2 for cholangio carcinoma and cisplatin 35mg/m2 and epirubicin 30mg/m2 for hepatocellular carcinoma. Dose and resimen of the agents for metastatic liver neoplasm are determined depending on the histological type. Increase the dose of cisplatin over every 3 cases by 5mg/m2 and establish the maximum treatment dose of each agent.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Written informed consent 2 No indication of surgical resection 3 Apparent increase in tumor size documented within 3 months after chemotherapy 4 Performance status of 0-2 based on the Eastern Cooperative Oncology Group(ECOG) score 5 Acceptable renal function (serum creatinine concentration less than 1.2mg/dl) 6 Acceptable bone marrow function (leukocyte count of more than 3,500/mm3, platelet count of more than 50,000/mm3) 7 Total bilirubin is less than 3mg/dl
Key exclusion criteria	1 Contraindication to angiography (due to severe side effect of contrast media) 2 High risk for general anesthesia 3 Advanced heart disease 4 Tumor invasion to Inferior vena cava or Portal vein trunk 5 Vascular anatomy not suitable for catheterization
Target sample size	20

Research contact person
Name of lead principal investigator	Satoru Murata
Organization	Nippon medical school
Division name	Department of Radiology
Address	Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	genji@nms.ac.jp

Public contact
Name of contact person	Satoru Murata
Organization	Nippon medical school
Division name	Department of Radiology
Address	Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	genji@nms.ac.jp

Sponsor
Institute	Nippon medical school
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nippon medical school
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	2012 Year 02 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 02 Month 04 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2016 Year 01 Month 05 Day
Date of closure to data entry	2016 Year 01 Month 05 Day
Date trial data considered complete	2016 Year 01 Month 05 Day
Date analysis concluded	2016 Year 05 Month 06 Day

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

Management information
Registered date	2012 Year 02 Month 06 Day
Last modified on	2016 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008515