HCC - Hepatocellular CarcinomaNCT07058649
Downstaging Prediction Model for HCC
An observational study of HCC - Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- How many people
- 369 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2025to 1 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients beyond UCSF criteria
Who may be able to join
- (A) Adult patients with HCC over the age of 18 (clinically diagnosed or pathologically diagnosed); (B) Liver function Child-Pugh score of Class A, or Class B with a score of 7 or below (including 7); (C) A single solid tumor with a diameter of ≥6.5 cm; three or more lesions, among which at least one tumor has a diameter >4.5 cm or the sum of the diameters is ≥8 cm; invasion of major blood vessels regardless of tumor size and number.
Who cannot join
- (A) Presence of distant metastasis outside the liver; (B) General performance status score (PS score) greater than 2 points.
About this study
Official title: Individualized Downstaging Prediction Model for HCC Beyond the UCSF Criteria
This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria.
Read the detailed description
This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria. It constructs a predictive model for downstaging treatment of liver cancer beyond the UCSF standards and completes external validation. This model will assist in clinical decision-making for the downstaging treatment of liver cancer beyond the UCSF criteria. Further downstaging methods are stratified to guide the selection of individualized downstaging treatment options for liver cancer beyond the UCSF standards.
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- downstaging, UCSF
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Successful downstaging | Failure downstaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Downstagingoutcomes
Successful downstaging is defined by meeting the UCSF criteria after downstaging; no invasion of the main trunk of the portal vein or the main trunk of the hepatic vein; and no lymph node invasion. The evaluation criteria used for interpretation are the mRECIST (modified Response Evaluation Criteria in Solid Tumors) standards.
Measured: 3 months after downstaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start16 Jul 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058649
- Sponsor's protocol ID
- 25288-0-02
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Downstaging Prediction Model for HCC Beyond the UCSF Criteria
- ClinicalTrials.gov ID
- NCT07058649
- Acronym / sponsor ID
- 25288-0-02
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- downstaging, UCSF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 16 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Jul 2025 (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.
This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria.
Detailed description
This study is a real-world, single-center study that collects imaging and clinical data from patients with HCC who are downstaged beyond the UCSF criteria. It constructs a predictive model for downstaging treatment of liver cancer beyond the UCSF standards and completes external validation. This model will assist in clinical decision-making for the downstaging treatment of liver cancer beyond the UCSF criteria. Further downstaging methods are stratified to guide the selection of individualized downstaging treatment options for liver cancer beyond the UCSF standards.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Successful downstaging | – | –Failure downstaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients beyond UCSF criteria
Key inclusion criteria (1 listed)
- (A) Adult patients with HCC over the age of 18 (clinically diagnosed or pathologically diagnosed); (B) Liver function Child-Pugh score of Class A, or Class B with a score of 7 or below (including 7); (C) A single solid tumor with a diameter of ≥6.5 cm; three or more lesions, among which at least one tumor has a diameter >4.5 cm or the sum of the diameters is ≥8 cm; invasion of major blood vessels regardless of tumor size and number.
Key exclusion criteria (1 listed)
- (A) Presence of distant metastasis outside the liver; (B) General performance status score (PS score) greater than 2 points.
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
Downstagingoutcomes
Time frame: 3 months after downstaging
Successful downstaging is defined by meeting the UCSF criteria after downstaging; no invasion of the main trunk of the portal vein or the main trunk of the hepatic vein; and no lymph node invasion. The evaluation criteria used for interpretation are the mRECIST (modified Response Evaluation Criteria in Solid Tumors) standards.
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 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Downstagingoutcomes (time frame: 3 months after downstaging). 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 10 Jul 2025.