Predictive Value of Albumin - Bilirubin Score and CRP - Albumin - Lymphocyte Index for HCC Prognosis After Radical Resection

April 16, 2025 updated by: Qiang Xu

The Predictive Value of the Albumin-Bilirubin Score and the C-Reactive Protein-Albumin-Lymphocyte Index for the Prognosis of Patients With Hepatocellular Carcinoma After Radical Resection

Evaluate the predictive value of the CALLY index and ALBI grading for the prognosis of patients with hepatocellular carcinoma (HCC) after radical resection, so as to provide a reference for clinical treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

China bears a heavy burden of liver cancer. In 2022, there were 370,000 new cases and 320,000 deaths, ranking 4th in incidence and 2nd in mortality among malignant tumors. HCC, accounting for over 80% of primary liver cancer, also has high incidence and fatality rates. Radical resection, the main cure method, has a 5-year recurrence rate over 60%, so identifying recurrence risk factors is crucial. Previously, the Child - Pugh score was used for liver function evaluation, but its assessment of ascites and hepatic encephalopathy was subjective. Quantitative systems like MELD also had limitations. Over 80% of HCC develops from cirrhosis, and inflammatory and immunonutritional indices are important in cancer development. NLR, PLR, etc., show inconsistent predictive power, and the CALLY index, though better, needs improvement. Bilirubin is a key predictor, and ALBI grading can precisely quantify liver function, related to HCC recurrence and survival. This study combines ALBI and CALLY to create a four - dimensional system, expected to reflect HCC recurrence risk. As this combined prediction research is scarce, this study evaluates their predictive value for HCC patients after radical resection, guiding clinical treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hepatocellular carcinoma (HCC) patients who underwent radical resection of hepatocellular carcinoma and sought medical treatment at Jiangxi Provincial Cancer Hospital

Description

Inclusion Criteria:

  • (1) Age ≥ 18 years old (2) Postoperative pathological examination confirmed hepatocellular carcinoma (HCC) (3) No other anti-tumor treatment was received before surgery (4) Radical resection was performed, and the pathological examination under the microscope showed negative surgical margins.

Exclusion Criteria:

  • (1) Complicated with other malignant tumors. (2) Incomplete clinicopathological data and prognostic information. (3) Received preoperative anti-cancer treatment. (4) Follow-up less than 1 month after hepatectomy. (5) Patients with surgical contraindications before surgery, such as portal vein tumor thrombus and distant metastasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence - free survival period
Time Frame: Patients who underwent hepatocellular carcinoma resection from Jan 2018 to Jan 2025 were recruited. The time from resection to tumor recurrence or end of follow - up was measured, with calculation cutoff in Apr 2025 and a maximum of 88 months.
It is the time interval from the patient's surgical resection to tumor recurrence or the end of follow - up. Early recurrence is defined as a tumor - free survival time of less than 2 years.
Patients who underwent hepatocellular carcinoma resection from Jan 2018 to Jan 2025 were recruited. The time from resection to tumor recurrence or end of follow - up was measured, with calculation cutoff in Apr 2025 and a maximum of 88 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Patients who underwent hepatocellular carcinoma resection from Jan 2018 to Jan 2025 were collected. Survival calculation was cutoff in Apr 2025. Measurement started from the initial radical resection until death, up to 88 months.
The length of time from either the start of treatment or diagnosis until the death of the patient from any cause.
Patients who underwent hepatocellular carcinoma resection from Jan 2018 to Jan 2025 were collected. Survival calculation was cutoff in Apr 2025. Measurement started from the initial radical resection until death, up to 88 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qiang Xu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025ky158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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