Unique ID issued by UMIN | UMIN000040488 |
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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 |
Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC
PRISM Study
Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC
PRISM Study
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
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.
Safety,Efficacy
Overall survival of each treatment regimen at each treatment line
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
2000
1st name | Masafumi |
Middle name | |
Last name | Ikeda |
National Cancer Center Hospital East
Department of hepatobiliary & pancreatic oncology
277-8577
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
masikeda@east.ncc.go.jp
1st name | Shinji |
Middle name | |
Last name | Itoh |
Kyushu University
Department of surgery and science, Graduate school of medical science
812-8582
Madade, Higashi-ku, Fukuoka-shi, Fukuoka,Japan
092-642-5466
itoshin@surg2.med.kyushu-u.ac.jp
Investigator Initiated Study Promotion Center
Eisai Co., Ltd.
Eli Lilly Japan K.K.
Profit organization
National Cancer Center Institutional Review Board
6-5-1 Kashiwanoha,Kashiwa,Chiba,Japan
04-7133-1111
irst@ml.res.ncc.go.jp
NO
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)
2020 | Year | 06 | Month | 01 | Day |
Unpublished
Open public recruiting
2020 | Year | 05 | Month | 21 | Day |
2020 | Year | 07 | Month | 06 | Day |
2020 | Year | 07 | Month | 01 | Day |
2025 | Year | 09 | Month | 30 | Day |
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.
2020 | Year | 05 | Month | 22 | Day |
2023 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046213
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