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

Last updated: March 26, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05667064
D419CC00026
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

  • Exclusion Criteria:

Study Design

Total Participants: 300
Study Start date:
May 10, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Research Site

    Aichi,
    Japan

    Site Not Available

  • Research Site

    Akita,
    Japan

    Site Not Available

  • Research Site

    Aomori,
    Japan

    Site Not Available

  • Research Site

    Chiba,
    Japan

    Site Not Available

  • Research Site

    Ehime,
    Japan

    Site Not Available

  • Research Site

    Fukui,
    Japan

    Site Not Available

  • Research Site

    Fukuoka,
    Japan

    Site Not Available

  • Research Site

    Fukushima,
    Japan

    Site Not Available

  • Research Site

    Gifu,
    Japan

    Site Not Available

  • Research Site

    Gunma,
    Japan

    Site Not Available

  • Research Site

    Hiroshima,
    Japan

    Site Not Available

  • Research Site

    Hokkaido,
    Japan

    Site Not Available

  • Research Site

    Hyogo,
    Japan

    Site Not Available

  • Research Site

    Ibaraki,
    Japan

    Site Not Available

  • Research Site

    Ishikawa,
    Japan

    Site Not Available

  • Research Site

    Iwate,
    Japan

    Site Not Available

  • Research Site

    Kagawa,
    Japan

    Site Not Available

  • Research Site

    Kagoshima,
    Japan

    Site Not Available

  • Research Site

    Kanagawa,
    Japan

    Site Not Available

  • Research Site

    Kochi,
    Japan

    Site Not Available

  • Research Site

    Kumamoto,
    Japan

    Site Not Available

  • Research Site

    Kyoto,
    Japan

    Site Not Available

  • Research Site

    Mie,
    Japan

    Site Not Available

  • Research Site

    Miyagi,
    Japan

    Site Not Available

  • Research Site

    Miyazaki,
    Japan

    Site Not Available

  • Research Site

    Nagano,
    Japan

    Site Not Available

  • Research Site

    Nagasaki,
    Japan

    Site Not Available

  • Research Site

    Nara,
    Japan

    Site Not Available

  • Research Site

    Niigata,
    Japan

    Site Not Available

  • Research Site

    Oita,
    Japan

    Site Not Available

  • Research Site

    Okayama,
    Japan

    Site Not Available

  • Research Site

    Okinawa,
    Japan

    Site Not Available

  • Research Site

    Osaka,
    Japan

    Active - Recruiting

  • Research Site

    Saga,
    Japan

    Site Not Available

  • Research Site

    Saitama,
    Japan

    Site Not Available

  • Research Site

    Shiga,
    Japan

    Site Not Available

  • Research Site

    Shimane,
    Japan

    Site Not Available

  • Research Site

    Shizuoka,
    Japan

    Site Not Available

  • Research Site

    Tochigi,
    Japan

    Site Not Available

  • Research Site

    Tokushima,
    Japan

    Site Not Available

  • Research Site

    Tokyo,
    Japan

    Site Not Available

  • Research Site

    Tottori,
    Japan

    Site Not Available

  • Research Site

    Toyama,
    Japan

    Site Not Available

  • Research Site

    Wakayama,
    Japan

    Site Not Available

  • Research Site

    Yamagata,
    Japan

    Site Not Available

  • Research Site

    Yamaguchi,
    Japan

    Site Not Available

  • Research Site

    Yamanashi,
    Japan

    Site Not Available

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