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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040488
Receipt No. R000046213
Scientific Title Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC
Date of disclosure of the study information 2020/06/01
Last modified on 2020/07/29

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Basic information
Public title Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC
Acronym PRISM Study
Scientific Title Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC
Scientific Title:Acronym PRISM Study
Region
Japan

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

Objectives
Narrative objectives1 Patients who are scheduled to receive systemic therapy for unresectable HCC are prospectively enrolled and investigate the therapeutic effect and safety of each treatment regimen in each treatment line.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival of each treatment regimen at each treatment line
Key secondary outcomes Progression free survival, overall response rate, disease control rate and time to treatment failure of each regimen at each treatment line
Grade 3 or greater adverse events of each regimen at each treatment line
Drug exposure (initial dose, duration of treatment and dose intensity, transition rate to next treatment) of each regimen at each treatment line

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients who histologically or clinically diagnosed with HCC.
2 Patients who scheduled for systemic therapy for HCC.
At the start of systemic therapy, other treatments (TACE, etc.) will not be used in combination.
3 20 years old or over.
4 Patients who obtained written informed consent of this clinical study.
Key exclusion criteria 1 Patients with a past history of systemic therapy (including molecular targeted therapies, immune checkpoint inhibitors, investigational drugs).
Patients with prior history of hepatectomy, local ablative therapy, TACE, and radiation therapy are not excluded.
2 Patients participating in clinical trials requiring some intervention, such as new agents.
3 Patients who are judged to be unsuitable to enroll in the study by the investigator.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Ikeda
Organization National Cancer Center Hospital East
Division name Department of hepatobiliary & pancreatic oncology
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email masikeda@east.ncc.go.jp

Public contact
Name of contact person
1st name Shinji
Middle name
Last name Itoh
Organization Kyushu University
Division name Department of surgery and science, Graduate school of medical science
Zip code 812-8582
Address Madade, Higashi-ku, Fukuoka-shi, Fukuoka,Japan
TEL 092-642-5466
Homepage URL
Email itoshin@surg2.med.kyushu-u.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Eisai Co., Ltd.
Eli Lilly Japan K.K.
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 Clinical Research Network Fukuoka Ethics Committee
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel 092-643-7171
Email mail@crnfukuoka.jp

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 近畿大学病院(大阪府)、国立がん研究センター東病院(千葉県)、九州大学病院(福岡県)、北海道大学病院(北海道)岩手医科大学附属病院(岩手県)、埼玉医科大学病院(埼玉県)、千葉大学医学部附属病院(千葉県)、杏林大学医学部付属病院(東京都)、国立がん研究センター中央病院(東京都)、国立国際医療研究センター病院(東京都)、武蔵野赤十字病院(東京都)、東京大学医学附属病院(東京都)、虎の門病院(東京都)、虎の門病院分院(神奈川県)、東邦大学医療センター大森病院(東京都)、東京医科歯科大学医学部附属病院(東京都)、神奈川県立がんセンター(神奈川県)、横浜市大学附属市民総合医療センター(神奈川県)、北里大学病院(神奈川県)、新潟大学医歯学総合病院(新潟県)、金沢大学附属病院(石川県)、大垣市民病院(岐阜県)、順天堂大学医学部附属静岡病院(静岡県)、愛知県がんセンター(愛知県)、京都府立医科大学附属病院(京都府)、大阪市立大学医学部附属病院(大阪府)、大阪府立病院機構 大阪国際がんセンター(大阪府)、大阪大学医学部附属病院(大阪府)、兵庫医科大学病院(兵庫県)、奈良県立医科大学附属病院(奈良県)、岡山大学病院(岡山県)、岡山市立市民病院(岡山県)、広島大学病院(広島県)、山口大学医学部附属病院(山口県)、徳島大学病院(徳島県)、愛媛県立中央病院(愛媛県)、国立病院機構 九州がんセンター(福岡県)、久留米大学病院(福岡県)、国立病院機構 九州医療センター(福岡県)、飯塚病院(福岡県)、長崎大学病院(長崎県)、熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 21 Day
Date of IRB
2020 Year 07 Month 06 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
The purpose of this study is to prospectively enroll patients who are scheduled to undergo systemic drug therapy for hepatocellular carcinoma in clinical practice and to construct real-world data on drug therapy for hepatocellular carcinoma. It is possible to clarify the treatment results of each treatment regimen in each treatment line from these real-world data, and we think that it is possible to answer various clinical questions.

Management information
Registered date
2020 Year 05 Month 22 Day
Last modified on
2020 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046213

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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