UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009026 |
|---|---|
| Receipt number | R000010572 |
| Scientific Title | A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Uncontrolled exploratory clinical study |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2012/10/02 19:56:36 |
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Basic information
Public title
A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Acronym
A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Scientific Title
A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Scientific Title:Acronym
A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to assess the efficasy and safety of combination therapy with continuous systemic 5-fluorouracil(5-FU) infusion and Sorafenib in patients with hepatocellular carcinoma(HCC) unresectable for locoregional therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
One-year survival
Key secondary outcomes
OS
TTP
RR/DCR
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The combination therapy of continuous intravenous infusion of 5-FU and 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)At least 20 years old when consent is given
2)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma found to be ineligible for resection or local treatment
3)Lesions measurable with contrast-enhanced CT or contrast-enhanced MRI
4)Child-Pugh class A
5)ECOG performance status (PS) of 0 or 1
6)Major organs functional, satisfying the following: In tests performed 14 or fewer days before enrollment:
Neutrophil count >=1500/microL
Platelet count >=50000/microL
Hemoglobin >= 8.5 g/dL
Total bilirubin < 2.0 mg/dL
Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 5 times the upper limit of the study center standard range
Serum creatinine (Cr) <=1.5 times the upper limit of the study center standard range
7)Capable of complying with requirements about visit days, medication, and laboratory tests
8)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Key exclusion criteria
1)History of use of Sorafenib or another molecular targeted drug
2)History of systemic chemotherapy
3)Clinically significant ascites (refractory ascites requiring drainage)
4)History of liver transplantation
5)Esophageal varices with the potential to bleed
6) Any of the following 12 or fewer months before enrollment in this research:
Myocardial infarction, unstable angina, cardiac failure, cerebrovascular disorder
7)Concurrent or prior hepatic encephalopathy
8)Brain tumor
9)On dialysis
10)Gastrointestinal hemorrhage during past month
11)Active multiple cancer
12)On a CYP3A4 inducer (rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone) or food including St. John's wort.
13) Any of the following concurrent diseases:
Grade 2 or greater arrhythmia or poorly controlled hypertension according to the JCOG/JSCO Japanese translation of the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE v 4.0)
14)Contraindicated for any of the study drugs
15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., shosaikoto)
16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related disease
17) Otherwise found ineligible as a subject by the researcher
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Chuma |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterogy and Hematorogy
Zip code
Address
kita 14,Nishi 5,Kita-ku, Sapporo, Japan
TEL
011-716-1161(5920)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Chuma |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterogy and Hematorogy
Zip code
Address
kita 14,Nishi 5,Kita-ku, Sapporo, Japan
TEL
011-716-1161(5920)
Homepage URL
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 18 | 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
| 2012 | Year | 10 | Month | 02 | Day |
Last modified on
| 2012 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010572
