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

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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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name