Imjudo & Imfinzi PMS
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients eligible for the study drugs according to the approved label in Korea
Provision of signed and dated written informed consent by the patient or legally acceptable representative
Disqualifiers
Other off-label indications according to the approved label in South Korea
Current participation in any interventional trial
Trial population
Patients who initiate treatment with study drugs after the contract date for the first time.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
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.Secondary outcomes
1
Objective Response Rate(ORR)
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Time frame
For 1 year from the first dose of the treatmentOther outcomes
1
Disease Control Rate (DCR)
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Time frame
For 1 year from the first dose of the treatmentSponsors and contacts
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Source ClinicalTrials.gov