UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004313 |
|---|---|
| Receipt number | R000005049 |
| Scientific Title | A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Non-blind dosage gradual increase study |
| Date of disclosure of the study information | 2010/10/03 |
| Last modified on | 2020/07/13 11:46:44 |
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Basic information
Public title
A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study
Acronym
A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study
Scientific Title
A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study
Scientific Title:Acronym
A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Non-blind dosage gradual increase study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine maximum tolerated dose(MTD) and recommended dose(RD) of combination therapy of 5-FU and sorafenib in patients with hepatocellular carcinoma unresectable and unsuitable for local therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
occurrence of dose limiting toxicity
Key secondary outcomes
Adversed events
Objective tumor response
Change of tumor markers
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
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) Age >= 20 years at informed consent.
2) Patients diagnosed with hepatocellular carcinoma by histologycally or clinically (with diagnostic imaging and tumor makers), and No indication for surgical resection, local therapy.
3) Patients who have target lesions that can be measured with imaging CT or imaging MRI.
At least one or more target regions are there that have no local therapy (surgery, radiation therapy, transarterial chemoembolization, transcatheter arterial infusion, radiofrequency ablation, percutaneous ethanol injection etc.).
Regions are evaluated measurable judged to be progress after any local therapy.
4) No carry-over effect or adverse drug reaction of prior treatments.
Make following intervals from previous treatments; 2 weeks from a surgery and percutaneous local therapy, 4 weeks from transarterial chemoembolization, transcatheter arterial infusion and radiations.
5) Child-pugh A
6) Performance status (ECOG scale):0 or 1
7) The function of the major organ is kept as satisfied by the following requirement.
Within 14 days before study entry,
Neutrophil >= 1,500/microL
Platelets >= 50,000/microL
Hemoglobin >= 10g/dL
Total bilirubin < 2.0mg/dL
AST or ALT <= 5 *Upper limit of Normal(ULN)
Cr <= 1.5 *ULN
8) Patients are considered to keeping procedure of this study such as visit, compliance, having laboratory tests.
9) Patients with written informed consent it was based on the full understanding and free will of themselves after having detailed explanations of the study.
Key exclusion criteria
11) Treatment with sorafenib or other molecular target drugs in past.
2) Any systemic chemotherapy in past.
3) Patients with ascites possessed clinical meaning. (Requiring drainage)
4) After liver transplantation
5) Esophageal varices with bleeding risk
6) Within 12 months before study entry, following events were happened; acute myocardial infarction, unstable angina, heart failure, cerebrovascular diseases.
7) Hepatic Encephalopathy. (Including as a previous disease)
8) Brain tumors.
9) Hemodialysis.
10) Gastrointestinal bleeding was happened within 1 month before study entry.
11) Active second primary malignancies.
12) Treating with CYP3A4 inducing agents.
(rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone etc.)
13) Patients with following complications; Arrhythmias coming under Grade2 or more of NCI CTCAE v4.0, uncontrolled hypertension
14) Contraindication of 5-FU and sorafenib
15) Patient with taking herbal medicine approved as a treatment of cancer. (shosaikoto, etc.)
16) Patients with infection of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases.
17) Any patients are considered unsuitable to participate in the study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Nakanishi |
Organization
Hokkaido University Hospital
Division name
The Third Department of Internal Medicine(Gastroenterology and Hematology)
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 | Mitsuru Nakanishi |
Organization
Hokkaido University Hospital
Division name
The Third Department of Internal Medicine(Gastroenterology and Hematology)
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
Sapporo city general hospital
Hokkaido Gastroenterology Hospital
Hospital Hakodate Hokkaido
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 03 | 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
0
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
| 2010 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2010 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005049
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