Hepatocellular CarcinomaNCT06544629
Imjudo & Imfinzi PMS
An observational study of Hepatocellular Carcinoma, run by AstraZeneca at 6 sites in South Korea.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 246 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 14 Apr 2025to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who initiate treatment with study drugs after the contract date for the first time.
Who may be able to join
- 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
Who cannot join
- Other off-label indications according to the approved label in South Korea
- Current participation in any interventional trial
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Research Site
Busan
- Recruiting
Research Site
Goyang
- Recruiting
Research Site
Seongnam
- Recruiting
Research Site
Seoul
- Not yet recruiting
Research Site
Seoul
- Recruiting
Research Site
Suwon
About this study
Official title: Imjudo & Imfinzi Post-Marketing Surveillance
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
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: For 1 year from the first dose of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Apr 2025
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544629
- Sponsor's protocol ID
- D419CR00029
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imjudo & Imfinzi Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT06544629
- Acronym / sponsor ID
- D419CR00029
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who initiate treatment with study drugs after the contract date for the first time.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Other off-label indications according to the approved label in South Korea
- Current participation in any interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
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.
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
1 secondary outcome
Objective Response Rate(ORR)
Time frame: For 1 year from the first dose of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by AstraZeneca at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.