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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013734
Receipt No. R000016015
Scientific Title A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Date of disclosure of the study information 2014/04/16
Last modified on 2020/10/19

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Basic information
Public title A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Acronym A phase I,II trial of HAIC with CDDP+5-FU for advanced HCC
Scientific Title A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Scientific Title:Acronym A phase I,II trial of HAIC with CDDP+5-FU for advanced HCC
Region
Japan

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

Objectives
Narrative objectives1 Safety, efficacy
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes safety
Key secondary outcomes efficacy

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 hepatic arterial infusion chemotherapy. 5-FU 300mg/m2, day 1 to 5, 5 to 19. CDDP 45mg/m2, 55mg/m2 or 65mg/m2, day2. 1 course = 28 days. continue till PD.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients were considered eligible for this study based on following criteria: advanced unresectable hepatocellular carcinoma; clinical stage III or IVA; no prior chemotherapy or radiation therapy within one month; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; age; 18 years; adequate baseline bone marrow function (hemoglobin level>9g/dl, neutrophil count>1,500/mm3 and platelet count >70,000/mm3) ; adequate hepatic function (total bilirubin level;2.0 mg/dl, aspartate aminotransferase and alanine aminotransferase levels five times the upper limit of normal); adequate renal function (serum creatinine level1.5 mg/dl); adequate respiratory and cardiac function; no metastatic lesion except for liver; and life expectancy at least three months. Written informed consent was obtained from all patients.
Key exclusion criteria complete obstruction of either celiac artery, common hepatic artery or splenic artery
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Miyanishi
Organization Sapporo Medical University School of Medicine
Division name Dept. of Medical Oncology
Zip code
Address South1, West16, Chuo-ku, Sapporo
TEL 011-611-2111
Email miyako@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Miyanishi
Organization Sapporo Medical University School of Medicine
Division name Dept. of Oncology and hematology
Zip code
Address South1, West16, Chuo-ku, Sapporo
TEL 0119611-2111
Homepage URL
Email miyako@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University School of Medicine
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
2014 Year 04 Month 16 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
2008 Year 05 Month 20 Day
Date of IRB
2008 Year 06 Month 24 Day
Anticipated trial start date
2008 Year 06 Month 24 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016015

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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