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

NCT ID: NCT05667064

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unresectable Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

\-

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

AstraZeneca KK

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Aichi, , Japan

Site Status WITHDRAWN

Research Site

Aichi, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Aichi, , Japan

Site Status RECRUITING

Research Site

Akita, , Japan

Site Status WITHDRAWN

Research Site

Aomori, , Japan

Site Status WITHDRAWN

Research Site

Aomori, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Chiba, , Japan

Site Status WITHDRAWN

Research Site

Chiba, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Ehime, , Japan

Site Status WITHDRAWN

Research Site

Ehime, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Fukui, , Japan

Site Status WITHDRAWN

Research Site

Fukuoka, , Japan

Site Status WITHDRAWN

Research Site

Fukuoka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Fukushima, , Japan

Site Status WITHDRAWN

Research Site

Gifu, , Japan

Site Status WITHDRAWN

Research Site

Gifu, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Gunma, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Gunma, , Japan

Site Status WITHDRAWN

Research Site

Hiroshima, , Japan

Site Status WITHDRAWN

Research Site

Hiroshima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Hiroshima, , Japan

Site Status RECRUITING

Research Site

Hokkaido, , Japan

Site Status WITHDRAWN

Research Site

Hokkaido, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Hokkaido, , Japan

Site Status RECRUITING

Research Site

Hyōgo, , Japan

Site Status WITHDRAWN

Research Site

Hyōgo, , Japan

Site Status RECRUITING

Research Site

Hyōgo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Ibaraki, , Japan

Site Status WITHDRAWN

Research Site

Ishikawa, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Ishikawa, , Japan

Site Status WITHDRAWN

Research Site

Kagawa, , Japan

Site Status WITHDRAWN

Research Site

Kagawa, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Kagoshima, , Japan

Site Status WITHDRAWN

Research Site

Kagoshima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Kanagawa, , Japan

Site Status WITHDRAWN

Research Site

Kochi, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Kochi, , Japan

Site Status WITHDRAWN

Research Site

Kumamoto, , Japan

Site Status WITHDRAWN

Research Site

Kyoto, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Kyoto, , Japan

Site Status WITHDRAWN

Research Site

Mie, , Japan

Site Status WITHDRAWN

Research Site

Mie, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Miyagi, , Japan

Site Status WITHDRAWN

Research Site

Miyazaki, , Japan

Site Status WITHDRAWN

Research Site

Miyazaki, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Nagano, , Japan

Site Status WITHDRAWN

Research Site

Nagasaki, , Japan

Site Status WITHDRAWN

Research Site

Nara, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Nara, , Japan

Site Status WITHDRAWN

Research Site

Niigata, , Japan

Site Status WITHDRAWN

Research Site

Numakunai, , Japan

Site Status WITHDRAWN

Research Site

Okayama, , Japan

Site Status WITHDRAWN

Research Site

Okayama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Okinawa, , Japan

Site Status WITHDRAWN

Research Site

Osaka, , Japan

Site Status WITHDRAWN

Research Site

Osaka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Osaka, , Japan

Site Status RECRUITING

Research Site

Ōita, , Japan

Site Status WITHDRAWN

Research Site

Ōita, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Saga, , Japan

Site Status WITHDRAWN

Research Site

Saitama, , Japan

Site Status WITHDRAWN

Research Site

Saitama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Shiga, , Japan

Site Status WITHDRAWN

Research Site

Shimane, , Japan

Site Status WITHDRAWN

Research Site

Shimane, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Shimane, , Japan

Site Status RECRUITING

Research Site

Shizuoka, , Japan

Site Status WITHDRAWN

Research Site

Shizuoka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Tochigi, , Japan

Site Status WITHDRAWN

Research Site

Tochigi, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Tokushima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Tokushima, , Japan

Site Status WITHDRAWN

Research Site

Tokyo, , Japan

Site Status WITHDRAWN

Research Site

Tokyo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Tokyo, , Japan

Site Status RECRUITING

Research Site

Tottori, , Japan

Site Status WITHDRAWN

Research Site

Toyama, , Japan

Site Status WITHDRAWN

Research Site

Wakayama, , Japan

Site Status WITHDRAWN

Research Site

Wakayama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Yamagata, , Japan

Site Status WITHDRAWN

Research Site

Yamaguchi, , Japan

Site Status WITHDRAWN

Research Site

Yamaguchi, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Yamanashi, , Japan

Site Status ACTIVE_NOT_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D419CC00026

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.