Effect of Nutritional Indices on the Prognosis of HCC Patients

NCT ID: NCT05635279

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-05-09

Brief Summary

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Primary liver cancer has recently ranked among the leading causes of cancer death, with hepatocellular carcinoma (HCC) accounting for 75%-85% of these cases. In recent years, immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) have achieved good results in the treatment of advanced HCC patients. So far, there is a lack of studies exploring the relationship between nutritional index and the prognosis of HCC patients treated with ICIs combined with TKIs, and there are few studies on the prognostic value of nutritional index in HCC patients treated with transarterial chemoembolization (TACE). This retrospective study aims to analyze the prognostic value of prognostic nutritional index(PNI),body mass index (BMI), psoas muscle index(PMI)and geriatric nutritional risk index (GNRI) in HCC patients who received ICIs combined with TKIs or TACE, and to provide reference for the selection of nutritional intervention programs for HCC patients.

Detailed Description

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Patients who confirmed HCC in the Second Affiliated Hospital of Chongqing Medical University were enrolled in the retrospective study. The subjects were divided into two cohorts, both of which met the inclusion and exclusion criteria.The data needed to be collected included age, gender, height and weight at initial treatment and regular follow-up. Blood routine, liver function, kidney function, coagulation function, electrolytes, PIVKA-II, AFP, HBV-DNA, CT, MRI information, China liver cancer staging (CNLC), complications, treatment plan, etc. Follow-up time after initiation of treatment and time of death or significant disease progression. The survival was estimated by the Kaplan-Meier method and curves were compared by the log-rank test.Logistic regression was used to univariate and multivariate analyze the effect of variables on the outcome. Variables with P\<0.05 on a univariate analysis were subjected to a multivariate analysis.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCC patients who received ICIs combined with TKIs

HCC patients who received ICIs combined with TKIs regularly and periodically.

Intervention Type OTHER

HCC patients treated with TACE

HCC patients who underwent TACE as initial treatment.

Intervention Type OTHER

Interventions

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Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Cohort 1:HCC patients received ICIs combined with TKIs regularly and periodically.

Cohort 2:HCC patients who underwent TACE as initial treatment.

Exclusion Criteria

1. Patients with systemic malignant tumors other than HCC.
2. Patients with severe hypertension, diabetes, coronary heart disease, systemic infection and other serious diseases.
3. patients with immunodeficiency or autoimmune diseases.
4. Patients with severe malnutrition.
5. Not adhering to regular and periodic treatment.
6. Patients without regular follow-up or with missing data to be collected.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juan Kang

OTHER

Sponsor Role lead

Responsible Party

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Juan Kang

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Juan Kang, M.D.

Role: STUDY_CHAIR

The Second Affiliated Hospital of Chongqing Medical University

Locations

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The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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Luo N, Li H, Luo Y, Hu P, Liang L, Zhang R, Zhang D, Cai D, Kang J. Prognostic significance of psoas muscle index in male hepatocellular carcinoma patients treated with immune checkpoint inhibitors and tyrosine kinase inhibitors. Hum Vaccin Immunother. 2023 Aug;19(2):2258567. doi: 10.1080/21645515.2023.2258567. Epub 2023 Sep 20.

Reference Type DERIVED
PMID: 37728115 (View on PubMed)

Other Identifiers

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2022-182

Identifier Type: -

Identifier Source: org_study_id

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