Assessing the safety and effectiveness of Imjudo and Imfinzi in treating liver cancer
Imjudo & Imfinzi Post-Marketing Surveillance
This study is testing whether the drugs Imjudo and Imfinzi are safe and effective for people with liver cancer in real-world settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 246 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 6 sites (Busan and 5 other locations) |
| Trial ID | NCT06544629 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of the drugs Imjudo and Imfinzi in patients with hepatocellular carcinoma who are treated according to approved indications in Korea. The primary objective focuses on assessing the safety of these medications, while secondary and exploratory objectives will evaluate their effectiveness in a real-world setting. The study will involve patients who meet specific eligibility criteria and have provided informed consent.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with hepatocellular carcinoma who are eligible for treatment with Imjudo and Imfinzi according to the approved label in Korea.
Not a fit: Patients currently participating in any interventional trial or those seeking off-label treatment indications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world safety and effectiveness of Imjudo and Imfinzi for liver cancer patients.
How similar studies have performed: While this study focuses on a specific real-world assessment, similar studies evaluating the effectiveness of cancer treatments have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Patients eligible for the study drugs according to the approved label in Korea 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion criteria: 1. Other off-label indications according to the approved label in South Korea 2. Current participation in any interventional trial
Where this trial is running
Busan and 5 other locations
- Research Site — Busan, South Korea (Recruiting)
- Research Site — Goyang, South Korea (Recruiting)
- Research Site — Seongnam, South Korea (Recruiting)
- Research Site — Seoul, South Korea (Recruiting)
- Research Site — Seoul, South Korea (Not_yet_recruiting)
- Research Site — Suwon, South Korea (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.