Hepatocellular Carcinoma (HCC)NCT07782632
Liver Volume Metrics for Predicting Immunotherapy Prognosis in Unresectable Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC), run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This multicenter retrospective cohort study aims to evaluate the prognostic value of functional liver volume and total liver volume in patients with unresectable hepatocellular carcinoma (HCC) undergoing immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Baseline Liver Volume Volumetric Analysis
- How many people
- 467 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with unresectable hepatocellular carcinoma (HCC) who received immunotherapy across multiple medical centers, including the First Affiliated Hospital of University of Science and Technology of China, Zhengzhou University First Affiliated Hospital, and Fuyang Second People's Hospital, who met all specified inclusion and exclusion criteria.
Who may be able to join
- Age >= 18 years.
- Clinically or histologically confirmed unresectable hepatocellular carcinoma (HCC).
- Received immunotherapy as part of their tumor treatment regimen.
- Availability of high-quality baseline pre-treatment imaging data suitable for functional liver volume and total liver volume segmentation.
- Complete clinical and follow-up survival data.
Who cannot join
- - Prior surgical resection or liver transplantation for HCC.
- Co-existence of other concurrent primary malignant tumor types.
- Severe image artifacts or technical limitations that prevent robust liver volume quantification.
- Incomplete medical records, missing key baseline clinical data, or loss to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Jizhou Wang, +86-551-62282931, wangjoe@ustc.edu.cn
About this study
Official title: Prediction of Immunotherapy Prognosis in Patients With Unresectable Hepatocellular Carcinoma Based on Functional Liver Volume and Total Liver Volume: A Multicenter Retrospective Cohort Study
This multicenter retrospective cohort study aims to evaluate the prognostic value of functional liver volume and total liver volume in patients with unresectable hepatocellular carcinoma (HCC) undergoing immunotherapy. The study explores whether baseline liver volume metrics can effectively predict survival outcomes and treatment responses in this patient population to assist in clinical decision-making.
Read the detailed description
This study retrospectively analyzes the clinical, laboratory, and imaging data of patients with unresectable hepatocellular carcinoma (HCC) who received immunotherapy across multiple clinical centers. Pre-treatment imaging data will be utilized to segment and quantify functional liver volume and total liver volume. Statistical and survival analyses will be performed to evaluate the correlation between these volumetric metrics and patient prognosis, including overall survival and progression-free survival, aiming to establish a robust stratification approach for individualized treatment strategies.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Baseline Liver Volume Volumetric Analysis
- Keywords
- Immunotherapy, Functional Liver Volume, Total Liver Volume, Prognosis, Multicenter Study
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Liver Volume Volumetric AnalysisOther
An observational evaluation based on the quantification of baseline pre-treatment functional liver volume (FLV) and total liver volume (TLV) derived from imaging datasets. These liver volume metrics are analyzed in correlation with clinical data to assess their prognostic potential for treatment response and overall survival in patients with unresectable hepatocellular carcinoma (HCC) receiving immunotherapy. No experimental treatment allocation or clinical intervention is performed.
| Study group | Role | What they receive |
|---|---|---|
| Unresectable HCC Immunotherapy Cohort | A multicenter retrospective cohort consisting of patients with unresectable hepatocellular carcinoma (HCC) who received immunotherapy. Baseline pre-treatment clinical and imaging data are reviewed to segment and evaluate functional liver volume and total liver volume metrics. These volumetric parameters are analyzed to determine their prognostic value regarding survival outcomes and treatment responses in this patient population. Receives: Other: Baseline Liver Volume Volumetric Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is defined as the time from the initiation of immunotherapy to the date of death from any cause, or the date of the last follow-up for surviving patients.
Measured: Up to 36 months
Overall Survival (OS)
Overall survival is defined as the time from the initiation of immunotherapy to the date of death from any cause, or the last follow-up date for surviving patients.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jan 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- Retrospective
- Enrolment
- 467 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782632
- Sponsor's protocol ID
- 2026KY-247
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Immunotherapy Prognosis in Patients With Unresectable Hepatocellular Carcinoma Based on Functional Liver Volume and Total Liver Volume: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07782632
- Acronym / sponsor ID
- 2026KY-247
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Immunotherapy, Functional Liver Volume, Total Liver Volume, Prognosis, Multicenter Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 467 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Aug 2026 (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 multicenter retrospective cohort study aims to evaluate the prognostic value of functional liver volume and total liver volume in patients with unresectable hepatocellular carcinoma (HCC) undergoing immunotherapy. The study explores whether baseline liver volume metrics can effectively predict survival outcomes and treatment responses in this patient population to assist in clinical decision-making.
Detailed description
This study retrospectively analyzes the clinical, laboratory, and imaging data of patients with unresectable hepatocellular carcinoma (HCC) who received immunotherapy across multiple clinical centers. Pre-treatment imaging data will be utilized to segment and quantify functional liver volume and total liver volume. Statistical and survival analyses will be performed to evaluate the correlation between these volumetric metrics and patient prognosis, including overall survival and progression-free survival, aiming to establish a robust stratification approach for individualized treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable HCC Immunotherapy Cohort | – | Other: Baseline Liver Volume Volumetric AnalysisA multicenter retrospective cohort consisting of patients with unresectable hepatocellular carcinoma (HCC) who received immunotherapy. Baseline pre-treatment clinical and imaging data are reviewed to segment and evaluate functional liver volume and total liver volume metrics. These volumetric parameters are analyzed to determine their prognostic value regarding survival outcomes and treatment responses in this patient population. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with unresectable hepatocellular carcinoma (HCC) who received immunotherapy across multiple medical centers, including the First Affiliated Hospital of University of Science and Technology of China, Zhengzhou University First Affiliated Hospital, and Fuyang Second People's Hospital, who met all specified inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Age >= 18 years.
- Clinically or histologically confirmed unresectable hepatocellular carcinoma (HCC).
- Received immunotherapy as part of their tumor treatment regimen.
- Availability of high-quality baseline pre-treatment imaging data suitable for functional liver volume and total liver volume segmentation.
- Complete clinical and follow-up survival data.
Key exclusion criteria (4 listed)
- - Prior surgical resection or liver transplantation for HCC.
- Co-existence of other concurrent primary malignant tumor types.
- Severe image artifacts or technical limitations that prevent robust liver volume quantification.
- Incomplete medical records, missing key baseline clinical data, or loss to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Liver Volume Volumetric AnalysisAn observational evaluation based on the quantification of baseline pre-treatment functional liver volume (FLV) and total liver volume (TLV) derived from imaging datasets. These liver volume metrics are analyzed in correlation with clinical data to assess their prognostic potential for treatment response and overall survival in patients with unresectable hepatocellular carcinoma (HCC) receiving immunotherapy. No experimental treatment allocation or clinical intervention is performed. | Other | Unresectable HCC Immunotherapy Cohort |
Primary outcome
Overall Survival (OS)
Time frame: Up to 36 months
Overall survival is defined as the time from the initiation of immunotherapy to the date of death from any cause, or the date of the last follow-up for surviving patients.
Overall Survival (OS)
Time frame: Up to 36 months
Overall survival is defined as the time from the initiation of immunotherapy to the date of death from any cause, or the last follow-up date for surviving patients.
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site 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 (HCC), run by Anhui Provincial Hospital at 1 site in China.
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 5 inclusion and 4 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Jizhou Wang, MD (+86-551-62282931, wangjoe@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 36 months). The study lists 2 primary outcomes in all. 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 24 Aug 2026.