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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005495
Receipt No. R000006503
Scientific Title Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study
Date of disclosure of the study information 2011/04/25
Last modified on 2015/04/24

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Basic information
Public title Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study
Acronym HCC-CDDP+Lipiodol-P2
Scientific Title Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study
Scientific Title:Acronym HCC-CDDP+Lipiodol-P2
Region
Japan

Condition
Condition HCC
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil in patients with advanced HCC who are not candidates for surgical resection, percutaneous ablation, or TACE.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate (RR)
Key secondary outcomes Safty
Tumor markers
Overall survival (OS)
6-months survival rate
1-year survival rate
Progression free survival (PFS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Transcatheter arterial chemothherapy using CDDP powder and iodized-oil.
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 with typical HCC diagnosed by histological or clinical examinations.
2)Patients without candidate for hepatectomy, ablation therapy, and TACE.
3)BCLC stage B or C.
4)Child-Pugh score of 8 or less.
5)Patients aged 20 years or over.
6)ECOG performance status of 0-2.
7)Patients with measurable target lesion on Modified RECIST.
8)Patients with at least 4 weeks interval from previous hepatectomy, ablation therapy, and TACE.
9)The function of the major organ is kept as satisfied, and laboratory values meet the following criteria within 14 days before study entry.
1.White blood cell >= 3,000/mm3
2.Platelet >= 50,000/uL
3.Hemogrobin >= 8.0g/dL
4.Total serum bilirubin =< 2.0mg/dL
5.AST and ALT =< 5 times upper limits of normal
6.Prothrombin time(%) >= 50%
7.Serum creatinine =< 1.5mg/dL
8.No abnormal findings requiring treatment in the electrocardiogram
10)Patients who are expected to live more than 3 months.
11)Patients who signed the informed consent to participate in this study.
Key exclusion criteria 1)History of previous treatment by platinum drugs.
2)Extrahepatic metastasis.
3)Advanced vascular or biliary invasion (Vp4,Vv3,B3,B4).
4)Sever arterio-portal shunt or arterio-venous shunt.
5)Difficult to perform transcatheter arterial chemotherapy.
6)History of the biliary tract reconstruction or treatment.
7)Patients with following severe complicating disease(except chronic hepatitis and liver cirrhosis).
1.Heart failure
2.Renal failure
3.Active infections(except viral hepatitis)
4.Active gastrointestinal bleeding
5.Active duplicative cancer
6.Hepatic encephalopathy or severe mental illness
8)Fever >= 38.0 degrees Celsius.
9)History of hypersensitivity to iodine-containing contrast agent, gadolinium-containing contrast agent, and platinum-containing drug.
10)Patients who are pregnant, lactating, suspected to be pregnant, or wish to become pregnant.
11)Patients who are concluded to be inappropriate to participate in this study by their physicians.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruyuki Takaki
Organization Mie University School of Medicine
Division name Department of Radiology
Zip code
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-5029
Email takaki-h@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruyuki Takaki
Organization Mie University School of Medicine
Division name Department of Radiology
Zip code
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-5029
Homepage URL
Email takaki-h@clin.medic.mie-u.ac.jp

Sponsor
Institute Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group
Institute
Department

Funding Source
Organization Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group
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
2011 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 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
2011 Year 04 Month 24 Day
Last modified on
2015 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006503

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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