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Trial Title:
Effect of Nutritional Indices on the Prognosis of HCC Patients
NCT ID:
NCT05635279
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
prognostic nutritional index
psoas muscle index
geriatric nutritional risk index
prognosis
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Kang, M.D.
Phone:
+8613996112052
Email:
68368892@qq.com
Start date:
November 1, 2022
Completion date:
May 2024
Lead sponsor:
Agency:
Juan Kang
Agency class:
Other
Source:
The Second Affiliated Hospital of Chongqing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635279
