- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934070
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
Active, not recruiting
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
Observational
Enrollment (Actual)
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
-
-
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
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
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
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
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)
April 3, 2025
Primary Completion (Actual)
April 3, 2025
Study Completion (Estimated)
April 16, 2025
Study Registration Dates
First Submitted
April 3, 2025
First Submitted That Met QC Criteria
April 16, 2025
First Posted (Actual)
April 18, 2025
Study Record Updates
Last Update Posted (Actual)
April 18, 2025
Last Update Submitted That Met QC Criteria
April 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Hepatocellular Carcinoma (HCC)
-
Zhejiang Haichang Biotech Co., Ltd.Not yet recruitingAdvanced Hepatocellular Carcinoma (HCC)
-
Ahmed Karam HelmyNot yet recruitingAdvanced Hepatocellular Carcinoma (HCC)Egypt
-
Fudan UniversityRecruitingAdvanced Hepatocellular Carcinoma (HCC)China
-
Bangladesh Medical UniversityRecruitingUnresectable Hepatocellular Carcinoma (HCC)Bangladesh
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingAdvanced Hepatocellular Carcinoma (HCC)
-
Zhejiang UniversityNot yet recruitingUnresectable Hepatocellular Carcinoma (HCC)China
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Not yet recruitingHepatocellular Carcinoma (HCC) | Unresectable Hepatocellular Carcinoma (HCC) | Liver Cancer AdultChina
-
Shen LinMETiS PharmaceuticalsRecruitingHepatocellular Carcinoma (HCC) | Liver Cancer, Adult | HCC - Hepatocellular Carcinoma | Metastatic Liver CancersChina
-
Fondazione IRCCS Policlinico San Matteo di PaviaCompletedHepatocellular Carcinoma (HCC) | MASLD-HCC | HCV_HCCItaly
-
Yoon Jun KimAstraZenecaRecruitingHepatocellular Carcinoma (HCC) | Unresectable Hepatocellular CarcinomaKorea, Republic of