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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002416
Receipt No. R000002961
Scientific Title Efficacy of intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib on advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)
Date of disclosure of the study information 2009/09/01
Last modified on 2013/09/02

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Basic information
Public title Efficacy of intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib on advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)
Acronym Intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib for advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)
Scientific Title Efficacy of intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib on advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)
Scientific Title:Acronym Intra-hepatic arterial chemotherapy (IHAC) vs. sorafenib for advanced hepatocellular carcinoma; a prospective cohort study (ISHCC-cohort)
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intra-hepatic arterial infusion chemotherapy and sorafenib in advanced hepatocellular carcinoma (multiple and/or vascular invasion)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression free survival
Response rate
Tumor control rate
Adverse events

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Sorafenib
Interventions/Control_2 B: intra-hepatic arterial chemotherapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI, or histologically confirmed hepatocellular carcinoma
2) no indication for transplantation, surgical resection, local ablation or transcatheter arterial embolization.
3) Child-Pugh A
4) >=20 years old
5) ECOG Performance Status 0-2
6) oral intake is possible
7) no extrahepatic lesion,
8) more than one measurable disease
9) Adequate baseline organ function:
neutrophil > 1,500/mm3, hemoglobin >=8.5g/dl, platelets > 75,000/mm3, serum bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <2.0mg/dL
10) written informed consent
11) life expectancy >=3 months
Key exclusion criteria 1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change
2) previous therapy for hepatocellular carcinoma within 30 days
3) inadequate for administration of sorafenib, 5-FU, cisplatin or interferon
4) active double cancer
5) severe complication
6) refractory ascites of pleural effusion
7) inappropriate for entry onto this study in the judgment of the investigator
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1 Takara-Machi, Kanazawa, Ishikawa
TEL 076-265-2233
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yamashita
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2861
Homepage URL
Email ytatsuya@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 金沢大学附属病院(石川県)
愛媛大学附属病院(愛媛県)
鳥取大学附属病院(鳥取県)
千葉大学附属病院(千葉県)
山口大学附属病院(山口県)
大阪大学附属病院(大阪府)
杏林大学附属病院(東京都)
東北大学附属病院(宮城県)
昭和大学附属病院(東京都)
兵庫医科大学附属病院(兵庫県)
近畿大学附属病院(大阪府)
岐阜大学附属病院(岐阜県)
岡山大学附属病院(岡山県)
虎ノ門病院(東京都)
久留米大学附属病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 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 Terminated
Date of protocol fixation
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 31 Day
Last modified on
2013 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002961

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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