Clinical trial NCT05667064: Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unresectable Hepatocellular Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-12-28
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable HCC

Brief 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.

Eligibility criteria: Inclusion Criteria:

All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy for their unresectable HCC.

-

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of ADRs
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Aichi
country: Japan
facility: Research Site
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References: