Imjudo & Imfinzi PMS

AstraZeneca

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT06544629

D419CR00029

Details and patient eligibility

About

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.

Full 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

Enrollment: 246 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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