UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007230
Receipt number R000008515
Scientific Title Retrograde isolated hepatic perfusion:Phase 1 trial
Date of disclosure of the study information 2012/02/06
Last modified on 2016/05/06 11:22:59

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Retrograde isolated hepatic perfusion:Phase 1 trial

Acronym

Phase 1 trial of R-IHP

Scientific Title

Retrograde isolated hepatic perfusion:Phase 1 trial

Scientific Title:Acronym

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


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



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

1st name
Middle name
Last name Satoru Murata

Organization

Nippon medical school

Division name

Department of Radiology

Zip code


Address

Sendagi 1-1-5, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

genji@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoru Murata

Organization

Nippon medical school

Division name

Department of Radiology

Zip code


Address

Sendagi 1-1-5, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

genji@nms.ac.jp


Sponsor or person

Institute

Nippon medical school

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2012 Year 02 Month 04 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008515


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name