Effect of Nutritional Indices on the Prognosis of HCC Patients

Hepatocellular Carcinoma Clinical Trial

Official title:

Study on the Effect of Nutritional Indices on the Prognosis of Hepatocellular Carcinoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635279
• Other study ID #: 2022-182
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: November 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Juan Kang, M.D.
• Phone: +8613996112052
• Email: 68368892[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Juan Kang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death due to hepatocellular carcinoma progression	November 2022 to May 2024
Secondary	Censored	Death due to other causes such as car accidents or loss to follow-up	November 2022 to May 2024