Hepatocellular Carcinoma (HCC)NCT06934070
Predictive Value of Albumin - Bilirubin Score and CRP - Albumin - Lymphocyte Index for HCC Prognosis After Radical Resection
An observational study of Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma (HCC) Prognosis, run by Qiang Xu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma (HCC) Prognosis
- How many people
- 287 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to 16 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular carcinoma (HCC) patients who underwent radical resection of hepatocellular carcinoma and sought medical treatment at Jiangxi Provincial Cancer Hospital
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- HCC, Hepatocellular Carcinoma, Albumin-Bilirubin Score, CALLY, ALBI, Hepatocellular carcinoma (HCC) prognosis
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence - free survival period
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.
Measured: 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 outcomes (1)
Overall Survival
The length of time from either the start of treatment or diagnosis until the death of the patient from any cause.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start3 Apr 2025
- Primary completion3 Apr 2025
- Study completion16 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiang Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiang Xu, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934070
- Sponsor's protocol ID
- 2025ky158
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06934070
- Acronym / sponsor ID
- 2025ky158
- Keywords
- HCC, Hepatocellular Carcinoma, Albumin-Bilirubin Score, CALLY, ALBI, Hepatocellular carcinoma (HCC) prognosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Qiang XuUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carcinoma (HCC) patients who underwent radical resection of hepatocellular carcinoma and sought medical treatment at Jiangxi Provincial Cancer Hospital
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma (HCC) Prognosis, run by Qiang Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.