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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004313
Receipt No. 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

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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)
Email

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
Email

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005049

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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