UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
Acronym	Biomarker study of sorafenib
Scientific Title	Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
Scientific Title:Acronym	Biomarker study of sorafenib
Region	Japan

Condition
Condition	Hepatocellulara carcinoma
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To explore biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
Basic objectives2	Others
Basic objectives -Others	To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who are indicated for sorafenib as the treatment of advanced or recurrent hepatocellular carcinoma 2. Patients who have never used sorafenib before 3. Patients with adequate organ function (to be confirmed within 2 weeks before the start of study treatment) a. Neutrophil count >1000 b. Platelets >50000 c. Hemoglobin >8.0 d. Total bilirubin <2.0 mg/dL e. Serum aspartate aminotransferase, serum alanine aminotransferase <200 IU/L 4. Child-Pugh score <8 5. Patients who have given written informed consent
Key exclusion criteria	1. Ineligible for dynamic CT or MRI; 2. Patients with cerebral metastasis; 3. Pregnant and breastfeeding women or those who may possibly be pregnant; 4. Patients with uncontrollable hypertension (BP>170 mmHg under medication) or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder; 5. Patients with moderate or severe renal dysfunction (Ccr < 30 mL/min) including those on dialysis; 6. Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month); 7. Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., carbamazepine, rifampicin, St. John's wort, etc. ) or drugs that may affect the serum concentration of sorafenib; 8. Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or 9. Patients judged as ineligible by the investigator in charge for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shunsuke Kondo
Organization	National Cancer Center Hospital
Division name	Internal medicine
Zip code
Address	5-1-1, Tsukiji, Chuo-ku
TEL	03-3542-2511
Email	shkondo@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Shunsuke Kondo
Organization	National Cancer Center Hospital
Division name	Internal medicine
Zip code
Address	5-1-1, Tsukiji, Chuoku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	shkondo@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Health and Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Institute of Health Sciences
Name of secondary funder(s)	Bayer Yakuhin Ltd.

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	国立がん研究センター東病院　 国立国際医療研究センター病院

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/30062555
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	2012 Year 08 Month 07 Day
Date of IRB	2012 Year 08 Month 07 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2018 Year 10 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events

Management information
Registered date	2012 Year 08 Month 30 Day
Last modified on	2019 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010355

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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