Imjudo & Imfinzi PMS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Imjudo & Imfinzi Post-Marketing Surveillance
Overview
Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.
Detailed description
Primary Objective:
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Secondary Objective:
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Exploratory Objective:
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Primary outcome measures
- Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) [Time frame: For Imjudo will be conducted for 90 days from the first dose of the treatment. For Imfinzi will be separately conducted for 1 year from the first dose.]
Secondary outcome measures (1)
- Objective Response Rate(ORR) [Time frame: For 1 year from the first dose of the treatment]
Eligibility criteria
Inclusion criteria
- Patients eligible for the study drugs according to the approved label in Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Exclusion criteria
- Other off-label indications according to the approved label in South Korea
- Current participation in any interventional trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 6 centers
- Research Site — Busan
- Research Site — Goyang
- Research Site — Seongnam
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Suwon
Identifiers
NCT: NCT06544629 · D419CR00029