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NCT Number: NCT07782632

Liver Volume Metrics for Predicting Immunotherapy Prognosis in Unresectable Hepatocellular Carcinoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

Location status: Recruiting

Location contact

Jizhou Wang

CONTACT

[email protected]

+86-551-62282931

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baseline Liver Volume Volumetric Analysis

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jizhou Wang, MD

CONTACT

[email protected]

+86-551-62282931

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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