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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.
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
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| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) | To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea | For 1 year from the first dose of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea | For 1 year from the first dose of the treatment |
Inclusion criteria:
Exclusion criteria:
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Patients who initiate treatment with study drugs after the contract date for the first time.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Busan | South Korea | |||
| Research Site |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Recruiting |
| Goyang |
| South Korea |
| Research Site | Recruiting | Seongnam | South Korea |
| Research Site | Recruiting | Seoul | South Korea |
| Research Site | Not yet recruiting | Seoul | South Korea |
| Research Site | Recruiting | Suwon | South Korea |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |