UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040488
Receipt number 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 2023/11/21 15:11:09

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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

2000


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 or person

Institute

Investigator Initiated Study Promotion Center

Institute

Department

Personal name



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

National Cancer Center Institutional Review Board

Address

6-5-1 Kashiwanoha,Kashiwa,Chiba,Japan

Tel

04-7133-1111

Email

irst@ml.res.ncc.go.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

2025 Year 09 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

2023 Year 11 Month 21 Day



Link to view the page

Value
https://center6.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