UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004776
Receipt number R000005687
Scientific Title Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Date of disclosure of the study information 2010/12/22
Last modified on 2018/02/13 07:45:20

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Basic information

Public title

Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma

Acronym

Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma

Scientific Title

Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma

Scientific Title:Acronym

Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma

Region

Japan


Condition

Condition

Cholangiocellular Carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety

Key secondary outcomes

Overall Survival (OS)
Progression Free Survival (PFS)
1-year Survival Rate
6 months Progression Free Survival
Response Rate (RR)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin

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 aged 20 Years or over
2) Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study
3) Patients diagnosed with typical cholangiocellular carcinoma by histologically proven and diagnostic imaging
4) Patients with tumor in the liver
5) Patients in whom complete resection of the tumor by hepatectomy cannot be expected to succeed.
6) Patients with an ECOG PS(Performance Status) Score of 0 or 1.
7) Patients who are expected to live more than 12 weeks.
8) Adequate organ function

Key exclusion criteria

1) History of malignant tumor
2) Severe cardiac disease
3) Active infection
4) History of HIV infection
5) Renal dialysis
6) Intracranial tumor
7) Clinically uncontrolled ascites or pleural effusion
8) Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
9) Prior history of chemotherapy with gemcitabine and cisplatin

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Yokosuka

Organization

Chiba University Hospital

Division name

Department of Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuou-ku, Chiba

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Sadahisa Ogasawara

Organization

Chiba University Hospital

Division name

Department of Gastroenterology

Zip code


Address


TEL


Homepage URL


Email

ogasawaras@graduate.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



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)



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

2010 Year 12 Month 22 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

Completed

Date of protocol fixation

2010 Year 12 Month 22 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 12 Month 22 Day

Last modified on

2018 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005687


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name