Trial Title:
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
NCT ID:
NCT05667064
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This investigation will be conducted to collect information of safety in patients with
unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of
IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI
monotherapy under actual use in the post-marketing setting.
Detailed description:
This investigation will be conducted to collect information of safety in patients with
unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of
IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI
monotherapy under actual use in the post-marketing setting.
The investigation will be conducted as one of the additional pharmacovigilance activities
in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the
Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the
purpose of application for reexamination under Article 14-4 of the Act on Securing
Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Criteria for eligibility:
Study pop:
Patients with unresectable HCC
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy
for their unresectable HCC.
- Exclusion Criteria:
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Akita
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aomori
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aomori
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Aomori
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ehime
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ehime
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Fukui
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Fukushima
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Fukushima
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Gifu
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Gifu
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Gunma
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Gunma
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ibaraki
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ibaraki
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Ishikawa
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ishikawa
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Iwate
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Iwate
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kagawa
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kagawa
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kagoshima
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kagoshima
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kochi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kumamoto
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mie
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Mie
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Miyagi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Miyagi
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Miyazaki
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Miyazaki
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nagano
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nagano
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Nara
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Oita
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Okinawa
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saga
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shiga
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shiga
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Shimane
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Shimane
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shimane
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shizuoka
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shizuoka
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tochigi
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tochigi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tokushima
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tokushima
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tottori
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tottori
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Toyama
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Toyama
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Toyama
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yamagata
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Yamagata
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Yamaguchi
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Yamaguchi
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Yamanashi
Country:
Japan
Status:
Active, not recruiting
Start date:
May 10, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05667064
