UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009771 |
|---|---|
| Receipt number | R000011426 |
| Scientific Title | A Prospective Cohort Study on the Prediction of Effectiveness of Sorafenib on the Basis of Angiogenesis-Related Cytokines |
| Date of disclosure of the study information | 2013/01/13 |
| Last modified on | 2022/07/22 12:38:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
nouso@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011426
