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
1 other identifier
observational
1,200
1 country
83
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Typical duration for all trials
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedStudy Start
First participant enrolled
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2025
CompletedJune 1, 2026
May 1, 2026
2.2 years
December 19, 2022
May 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of ADRs
24 weeks
Eligibility Criteria
Patients with unresectable HCC
You may qualify if:
- All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy for their unresectable HCC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Links
Study Officials
- STUDY DIRECTOR
Toshimitsu Tokimoto
AstraZeneca KK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2022
First Posted
December 28, 2022
Study Start
May 9, 2023
Primary Completion
July 21, 2025
Study Completion
July 21, 2025
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.