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Trial Title:
CT-based HVPG Assessment for Predicting the Prognosis of HCC With TACE (CHANCE-CHESS 2302)
NCT ID:
NCT05704192
Condition:
Hepatocellular Carcinoma
Portal Hypertension
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hypertension, Portal
Hypertension
Conditions: Keywords:
hepatocellular carcinoma
transarterial chemoembolization
portal hypertension
non-invasive imaging assessment
deep learning
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
TACE ± Systemic therapy
Description:
TACE: conventional TACE (cTACE) or drug-eluting beads TACE (dTACE); Systemic therapy:
programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) inhibitors,
vascular endothelial growth factor -tyrosine kinase inhibitor (VEGF-TKI)/bevacizumab,
PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, radiotherapy or chemotherapy.
Arm group label:
Clinically significant portal hypertension (CSPH) group
Arm group label:
non-CSPH group
Summary:
This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure
Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients
treated with transarterial chemoembolization (TACE).
Detailed description:
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the second
leading cause of cancer-related deaths globally. Transarterial chemoembolization (TACE)
is recommended as standard therapy for intermediate-stage HCC according to the current
guidelines and is also the most widely used in advanced HCC in real-world practice.
Portal hypertension increases the risk of hepatic decompensation, which impairs survival
in patients with HCC. Clinically significant portal hypertension is defined as >10 mmHg
increase in the hepatic vein pressure gradient (HVPG), and the current gold standard for
its assessment is direct measurement, through a transjugular approach. However, due to
its invasive character and high effort, HVPG measurement is not a standard tool in the
initial diagnostic evaluation of patients with HCC. This study aims to evaluate the
impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on
prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial
chemoembolization (TACE).
Criteria for eligibility:
Study pop:
Patients with HCC treated with TACE ± Systemic Treatment from January 2010 to December
2021.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Received at least 1 TACE treatment；
3. Contrast-enhanced computed tomography (CECT) examination within 1 month before the
first TACE treatment;
Exclusion Criteria:
1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed
hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are
not eligible;
2. Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) > 2;
3. History of liver or spleen resection;
4. Loss to follow-up;
5. CECT image data was incomplete, unclear, or artifact occurred.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gao-Jun Teng
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-Qing Wang
Facility:
Name:
Xiaolong Qi
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-Qing Wang
Start date:
May 4, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Zhongda Hospital
Agency class:
Other
Source:
Zhongda Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704192
