UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Cohort Study on the Prediction of Effectiveness of Sorafenib on the Basis of Angiogenesis-Related Cytokines
Acronym	The Prediction of Effectiveness of Sorafenib on the Basis of Angiogenesis-Related Cytokines
Scientific Title	A Prospective Cohort Study on the Prediction of Effectiveness of Sorafenib on the Basis of Angiogenesis-Related Cytokines
Scientific Title:Acronym	The Prediction of Effectiveness of Sorafenib on the Basis of Angiogenesis-Related Cytokines
Region	Japan

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

Objectives
Narrative objectives1	The objectives of this study are: to measure the concentrations of angiogenesis-related cytokines in blood before and after the start of treatment with sorafenib in patients with unresectable advanced HCC and confirm their usefulness as predictors of effectiveness of the treatment; and to investigate correlations between cytokine levels measured at the time of documentation of progressive disease (PD) and the subsequent treatment effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Time from sorafenib treatment initiation to 1st progression (1st TTP)
Key secondary outcomes	Overall survival (OS) Incidence of adverse events Tumor marker assessment Time from first disease progression to second progression (2nd TTP)

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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Blood samples will be collected on routine blood tests before and after the start of sorafenib treatment and at the time of suspension, resumption, and discontinuation of sorafenib treatment. A little more blood than usual will be drawn on each occasion to collect 5-mL blood samples used for assay. Plasma and serum processed from the blood samples will be stored.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients for whom sorafenib treatment is selected in clinical practice 2) Patients with histologically, cytologically, or radiologically (using contrast-enhanced CT or MRI) confirmed typical HCC 3) Patients with intrahepatic or extrahepatic lesion that is judged to be unresectable on diagnostic imaging 4) Patients 20 to <90 years of age at the time of informed consent 5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 6) Patients with adequate function of major organs on laboratory tests 1 month before enrollment (1) Neutrophils: >1,500/mm3 (2) Hemoglobin: >=8.5 g/dL (3) Platelets: >50,000/mm3 (4) Serum total bilirubin: <2.0 mg/dL (5) Serum AST/ALT: not more than 5 times the institution's upper limit of normal (ULN) (6) Serum creatinine: not more than 1.5 times the institution's ULN 7) Patients who have provided written informed consent for participation in this study
Key exclusion criteria	1) Patients with histologically confirmed mixed-type HCC or sarcomatous change 2) Patients with a history of molecular-targeted therapy 3) Patients with active double cancer (Patients who have early-stage cancer that does not appear to affect their prognosis and can be controlled by treatment may be enrolled in this study.) 4) Patients with any serious coexisting condition (e.g., ileus, interstitial pneumonia, pulmonary fibrosis, difficult-to-control diabetes mellitus, hypertension, cardiac failure, renal failure, hepatic failure, active peptic ulcer, varicose veins in danger of rupture, severe mental disorder or depression) 5) Patients with ascites and/or pleural effusion unresponsive to treatment 6) Patients judged by the principal investigator or subinvestigator to be unsuitable for participation for any other reason (to ensure the safe conduct of this study)
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichiro Nakamura
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL	086-235-7219
Email	shinnkmr@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Nouso
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL	086-235-7219
Homepage URL
Email	nouso@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	岡山大学病院（岡山県）岡山済生会病院（岡山県）・岡山市立市民病院（岡山県）・香川県立中央病院（香川県）・倉敷中央病院（岡山県）・津山中央病院（岡山県）・ 広島市立広島市民病院（広島県）・三豊総合病院（香川県）・福山市民病院（広島県）・福山医療センター（広島県）など

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 13 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
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 07 Month 07 Day
Date of IRB	2012 Year 11 Month 27 Day
Anticipated trial start date	2012 Year 11 Month 27 Day
Last follow-up date	2018 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2013 Year 01 Month 13 Day
Last modified on	2022 Year 07 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011426