Clinical trial · Observational
Imjudo & Imfinzi PMS
Imjudo & Imfinzi Post-Marketing Surveillance
NCT06544629CI-TRIAL-00097709recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
- timeFrame
- 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.
- description
- To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Secondary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- For 1 year from the first dose of the treatment
- description
- To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.