NCT05635279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2023

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

November 22, 2022

Last Update Submit

June 19, 2025

Conditions

Keywords

prognostic nutritional indexpsoas muscle indexgeriatric nutritional risk indexprognosis

Outcome Measures

Primary Outcomes (1)

  • Death

    Death due to hepatocellular carcinoma progression

    November 2022 to May 2024

Secondary Outcomes (1)

  • Censored

    November 2022 to May 2024

Study Arms (2)

HCC patients who received ICIs combined with TKIs

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

HCC patients treated with TACE

HCC patients who underwent TACE as initial treatment.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Cohort 1:HCC patients received ICIs combined with TKIs regularly and periodically.
  • Cohort 2:HCC patients who underwent TACE as initial treatment.

You may not qualify if:

  • Patients with systemic malignant tumors other than HCC.
  • Patients with severe hypertension, diabetes, coronary heart disease, systemic infection and other serious diseases.
  • patients with immunodeficiency or autoimmune diseases.
  • Patients with severe malnutrition.
  • Not adhering to regular and periodic treatment.
  • Patients without regular follow-up or with missing data to be collected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Juan Kang, M.D.

    The Second Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 2, 2022

Study Start

November 1, 2022

Primary Completion

January 7, 2023

Study Completion

May 9, 2023

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations