Effect of Nutritional Indices on the Prognosis of HCC Patients

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05635279
• Lead Sponsor: Juan Kang

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-01
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2024-01
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	November 2022 to May 2024	Death due to hepatocellular carcinoma progression

Secondary Outcome Measures

Name	Time	Method
Censored	November 2022 to May 2024	Death due to other causes such as car accidents or loss to follow-up

Trial Locations

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China