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Liver Volume Metrics for Predicting Immunotherapy Prognosis in Unresectable Hepatocellular Carcinoma

Prediction of Immunotherapy Prognosis in Patients With Unresectable Hepatocellular Carcinoma Based on Functional Liver Volume and Total Liver Volume: A Multicenter Retrospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07782632
Enrollment
467
Registered
2026-08-24
Start date
2019-01-01
Completion date
2026-12-30
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Immunotherapy, Functional Liver Volume, Total Liver Volume, Prognosis, Multicenter Study

Brief 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. 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.

Interventions

OTHERBaseline Liver Volume Volumetric Analysis

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.

Sponsors

Anhui Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* \- 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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival (OS)Up to 36 monthsOverall 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.

Countries

China

Contacts

CONTACTJizhou Wang, MD
wangjoe@ustc.edu.cn+86-551-62282931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026