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NCT05667064 Clinical Trial

Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:
Specific Use-results Study of IMJUDO Intravenous Infusion 25 mg, 300 mg / IMFINZI Intravenous Infusion 120 mg, 500 mg All Patient Investigation in Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05667064
Other study ID # D419CC00026
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy for their unresectable HCC. - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Aichi
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Chiba
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Ehime
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukuoka
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hiroshima
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hokkaido
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Hyogo
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Ibaraki
Japan Research Site Ishikawa
Japan Research Site Ishikawa
Japan Research Site Iwate
Japan Research Site Iwate
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kagawa
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kanagawa
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Kumamoto
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Kyoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Miyazaki
Japan Research Site Miyazaki
Japan Research Site Nagano
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nagasaki
Japan Research Site Nara
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okayama
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Osaka
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shimane
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tochigi
Japan Research Site Tochigi
Japan Research Site Tokushima
Japan Research Site Tokushima
Japan Research Site Tokushima
Japan Research Site Tokyo
Japan Research Site Tokyo
Japan Research Site Tokyo
Japan Research Site Tokyo
Japan Research Site Tottori
Japan Research Site Tottori
Japan Research Site Toyama
Japan Research Site Toyama
Japan Research Site Wakayama
Japan Research Site Wakayama
Japan Research Site Wakayama
Japan Research Site Yamagata
Japan Research Site Yamaguchi
Japan Research Site Yamaguchi
Japan Research Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ADRs 24 weeks
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Recruiting NCT04736121 - Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients N/A
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Withdrawn NCT02989870 - Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma Phase 1
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