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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012041
Receipt No. R000013260
Scientific Title Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors.
Date of disclosure of the study information 2013/10/15
Last modified on 2019/04/15

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Basic information
Public title Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors.
Acronym adjubant CDDP TAI for HCC with high recurrence risk factors.
Scientific Title Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors.
Scientific Title:Acronym adjubant CDDP TAI for HCC with high recurrence risk factors.
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Medicine in general Surgery in general Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy with CDDP, in patients with hepatocellular carcinoma with early recurrence factors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2 years recurrence rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
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 with 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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with curative hepatectomy
2) Patients with hepatocellular carcinoma diagnosed by histologial examination
3) Patients with early recurrence risk factors
4) Patients without recurrence
5) within 10 weeks after surgery
6) Male or female aged 20 years or older at the time of informed consent and younger than 85 years old
8) Patinets with chronic hepatitis or Child-Pugh class A, B cirrhosis
8) Patients with an ECOG Performance Status (PS) score of 0 or 1,2
9) Adequate organ function
a.Neutrophil>=3000 /mm3
b.PLT>= 50000 /mm3
c.Hb>= 8.0g/dL
d.T-Bil<= 3.0 mg/dL
e.ALB>2.5g/dl
f.AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
g.Cre<= within 1.5 times of normal limit
h.PT>=40%
i.No need of treatment on ECG
10) Life expectancy of at least 3 months
11) Patients obtained written informed consent
Key exclusion criteria 1) Patients with mixed hepatocellular and cholangiocellular carcinoma diagnosed by histologial examination
2) Severe arterio-portal or arterio-venous shunts in the liver
3) Patinets with difficulty with drug arrival to hepatic lesion
4) Other uncontrolled severe illness
a. With severe cardiac failure
b. With severe renal function disease
c. With active infectious disease except viral hepatitis
d. With active gastrointestinal hemorrhage
e. With active other malignancies
f. With hepatic encephalopathy and severe mental disorder
g. With clinically significant refractory ascites or pleural effusion
5) Allergic reaction to iodine contrast material, gadolinium contrast material, or platium containing agent.
6)Patients medicated with steroid
7) A pregnant woman, or a woman suspected of pregnancy.
8) Patients who are concluded to be inappropriate to participate in this study by their physitians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization Hiroshima University Hospital
Division name Department of Gastroenterology and Metabolism,Department of Surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5191
Email chayama@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Aikata
Organization Hiroshima University Hospital
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5191
Homepage URL
Email aikata@hiroshima-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabolism,Hiroshima University Hospital
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 15 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
2013 Year 06 Month 27 Day
Date of IRB
2013 Year 10 Month 07 Day
Anticipated trial start date
2013 Year 10 Month 15 Day
Last follow-up date
2019 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
2013 Year 10 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013260

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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