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

Recruiting

• Conditions: Portal Hypertension; Hepatocellular Carcinoma
• Interventions: Procedure: TACE ± Systemic therapy

• Registration Number: NCT05704192
• Lead Sponsor: Zhongda Hospital

Brief 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).

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Status Verified: 2023-05
• Study Start: 2023-05-04
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 373

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-CSPH group	TACE ± Systemic therapy	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.
Clinically significant portal hypertension (CSPH) group	TACE ± Systemic therapy	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	up to approximately 2 years	The OS is defined as the time from the initiation of any treatment to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression free survival(PFS) per mRECIST	up to approximately 2 years	The PFS is defined as the time from the initiation of any treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Objective response rate(ORR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)	up to approximately 2 years	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per mRECIST.

Trial Locations

Locations (2)

Gao-Jun Teng; 🇨🇳 Nanjing, China

Xiaolong Qi; 🇨🇳 Nanjing, China