UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009094 |
|---|---|
| Receipt number | R000010200 |
| Scientific Title | Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/10/11 |
| Last modified on | 2019/04/12 09:44:16 |
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Basic information
Public title
Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma
Acronym
HICS 55
Scientific Title
Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma
Scientific Title:Acronym
HICS 55
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 1-year survival rate
Key secondary outcomes
The 2-year survival rate
Over all survival
Respose rate of HAIC
Survival rate according to HAIC response
Time to progression of HAIC
Response rate of sorafenib
Survival rate according to sorafenib response
Adverse events
Liver function process
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 | Maneuver |
Interventions/Control_1
Hepatic arterial infusion chemotherapy
(Low-Dose FP)
Patients become refractory HAIC ,
followed by sorafenib.
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) 20 Years and older.
2) Life expectancy of at least 12 weeks at the pre-treatment evaluation.
3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI.
4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
5) At least 4 weeks since last therapy for HCC.
6) Patients with no sorafenib and hepatic arterial infusion chemotherapy.
7) Intrahepatic tumor which affects patient'prognosis.
8) Extrahepatic tumor apread which not affects patient's prognosis.
9) ECOG Performance status of 0 or 1.
10) Child-Pugh 5,6,7
12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
Granulocyte >= 3000/mm3
Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl
Total serum bilirubin <= 3 mg/dl
serum albimin>=2.8
Serum creatinine <= 1.5 mg/dl
prothrombin consumption test>=50%
Amylase <= 2 times upper limit of normal
12) Written Informed Consent must be obtained.
Key exclusion criteria
1) With other malignant disease.
2) A pregnant woman, or a woman suspected of pregnancy.
3) With severe infectious disease.
4) With history of severe allergy.
5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP.
7) With severe bone marrow supression.
8) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro-
intestinal bleeding.
9) Serious hypertension
10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Target sample size
55
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
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5191
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
aikata@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Institute
Department
Personal name
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
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
| 2012 | Year | 10 | Month | 11 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2016 | Year | 12 | 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
| 2012 | Year | 10 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010200
