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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05667064

Enrollment

1200

Registered

2022-12-28

Start date

2023-05-09

Completion date

2025-07-21

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Hepatocellular Carcinoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Incidence of ADRs	24 weeks

Contacts

STUDY_DIRECTORToshimitsu Tokimoto

AstraZeneca KK

Outcome results