CT-based HVPG Assessment for Predicting the Prognosis of HCC With TACE (CHANCE-CHESS 2302)

Southeast University

Status: Enrolling

Conditions: Portal Hypertension; Hepatocellular Carcinoma

Treatments: Procedure: TACE ± Systemic therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05704192

CHANCE-CHESS 2302

Details and patient eligibility

About

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).

Full 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).

Enrollment: 373 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

373 participants in 2 patient groups

Clinically significant portal hypertension (CSPH) group

Description:

A CT-based HVPG Score, whose computed formula was: 17.37-4.91\*ln(Liver/Spleen volume ratio) +3.8\[If presence of peri-hepatic ascites\],was used to diagnose CSPH (HVPG\>10mmHg) with a cut-off value 11.606.

Treatment:

Procedure: TACE ± Systemic therapy

non-CSPH group

Description:

A CT-based HVPG Score, whose computed formula was: 17.37-4.91\*ln(Liver/Spleen volume ratio) +3.8\[If presence of peri-hepatic ascites\],was used to diagnose CSPH (HVPG\>10mmHg) with a cut-off value 11.606.

Treatment:

Procedure: TACE ± Systemic therapy