UMIN-CTR Clinical Trial

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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