Hepatocellular Carcinoma
Conditions
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
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 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 |
Countries
South Korea
Contacts
Primary ContactAstraZeneca Clinical Study Information Center
Outcome results
None listed