CClinicalTrials.gg
RecruitingNCT06544629Updated Oct 5, 2026

Imjudo & Imfinzi PMS

An observational study in Hepatocellular Carcinoma, sponsored by AstraZeneca. Recruiting at 6 sites in South Korea. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by AstraZeneca · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
246
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma, Hepatocellular

3,183 studies on the registry are indexed under Carcinoma, Hepatocellular; 955 are open to participants now.

This study's planned enrollment of 246 is above the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who initiate treatment with study drugs after the contract date for the first time.

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

Exclusion criteria:

  1. Other off-label indications according to the approved label in South Korea
  2. Current participation in any interventional trial
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
246 participants (estimated)
Patient registry
No
06

What researchers measure

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 treatment

Other 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 treatment

07

Study locations

5 of 6 sites recruiting
  • Research Site
    Busan, South Korea
    Recruiting
  • Research Site
    Goyang, South Korea
    Recruiting
  • Research Site
    Seongnam, South Korea
    Recruiting
  • Research Site
    Seoul, South Korea
    Recruiting
  • Research Site
    Seoul, South Korea
    Not yet recruiting
  • Research Site
    Suwon, South Korea
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
Feb 28, 2029→Dec 30, 2029
Oct 5, 2026
Study completion
Feb 28, 2029→Dec 30, 2029
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion Feb 28, 2029→Dec 30, 2029
    Study completion Feb 28, 2029→Dec 30, 2029
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06544629
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Apr 14, 2025
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Oct 5, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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