ClinicalTrials.gg
RecruitingNCT07782632Updated Aug 24, 2026

Liver Volume Metrics for Predicting Immunotherapy Prognosis in Unresectable Hepatocellular Carcinoma

An observational study in Hepatocellular Carcinoma (HCC), sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Anhui Provincial Hospital · Observational

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
467
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Carcinoma, Hepatocellular by Anhui Provincial Hospital — 6 open to participants now, 7 under way, none of them phase 3. Carcinoma, Hepatocellular · Anhui Provincial Hospital.

Started
2019
the only one that year
Observational
3 of 10
1 open now
Registered
9th of 10
by date

Among the 10 studies in Carcinoma, Hepatocellular by Anhui Provincial Hospital, this one is the only one that started in 2019, is one of 3 observational ones, and was the 9th registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

6 of the 10 studies in Carcinoma, Hepatocellular by Anhui Provincial Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Hepatocellular Carcinoma (HCC)

Keywords

  • Immunotherapy
  • Functional Liver Volume
  • Total Liver Volume
  • Prognosis
  • Multicenter Study
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >= 18 years.
  • Clinically or 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
467 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Baseline Liver Volume Volumetric Analysis

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 36 months

  2. 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.

    Time frame: Up to 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Dec 2026, 95 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 24, 2026
StartActual
Jan 1, 2019
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07782632
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Jan 1, 2019
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Aug 24, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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