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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002590
Receipt No. R000003166
Scientific Title A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma
Date of disclosure of the study information 2009/10/07
Last modified on 2014/05/30

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Basic information
Public title A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma
Acronym A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma
Scientific Title A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma
Scientific Title:Acronym A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and to determine recommended dose of combination therapy of TS-1 and sorafenib in patients with advanced hepatocellular carcinoma
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Incident of dose limiting toxcity
Key secondary outcomes Adversed event
Response rate
Disease control rate
Time to progression
Progression free survival
Overall survival

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 TS-1 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)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images
2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy)
3)At least 1 target lesion measurable
4)Performance status (ECOG scale): 0,1
5)Age >= 20 years
6)Adequate bone marrow, liver, renal and cardiac function as assessed by the following
(a)Neutrophil >= 1500/mm3
(b)Hemoglobin >= 9.0 g/dl
(c)Platelets >= 50000/mm3
(d)Total bilirubin < 3.0mg/dl
(e)Liver transaminases <= 10 x Upper limit of Normal(ULN)
(f)ALB >= 2.8 g/dl
(g)Cre <= ULN
(h)PT >= 40%
7)Child-pugh A
8)Patients can take food and drugs oral
9)Life expectancy of at least 12 weeks
10)Written informed consent
Key exclusion criteria 1)Previous therapy for hepatocellular carcinoma within 30days before study entry
2)Major surgery within 30 days before study entry or surgery within 15 days before study entry
3)Portal vein tumor thrombs in the main trunk
4)Uncontrollable hypertension
5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics
6)Hepatoencepharopathy. Brain lesions with clinical symptoms
7)Central nerve system tumor(including brain metastasis)
8)Bone metastasis with clinical symptoms
9)Active infection(except HBV and HCV infection)
10)Evidence of serious gastrointestinal bleeding within 30days before study entry
11)Gastro-esophazeal varices requiring preventive treatment
12)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment
13)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence)
14)Severe hypersensitivity of TS-1 or sorafenib
15)Severe complication
16)Any patients judged by the investigator to be unfit to participate in the study
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiko Kanai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Tyuuou-ku, Chiba
TEL 043-226-2083
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Ooka
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Tyuuou-ku, Chiba
TEL 043-226-2083
Homepage URL
Email

Sponsor
Institute Chiba 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
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 09 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
2009 Year 10 Month 07 Day
Last modified on
2014 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003166

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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