Imjudo & Imfinzi PMS
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT06544629
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 246
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) 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. To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
- Secondary Outcome Measures
Name Time Method Objective Response Rate(ORR) For 1 year from the first dose of the treatment To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Trial Locations
- Locations (1)
Research Site
🇰🇷Suwon, Korea, Republic of