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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Non-invasive CT-based Hepatic Venous Pressure Gradient Assessment for Predicting the Prognosis of Hepatocellular Carcinoma With Transarterial Chemoembolization (CHANCE-CHESS 2302): A Multicenter Retrospective Study

Conditions
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Hepatocellular Carcinoma, Portal Hypertension

Intervention / Treatment
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* Procedure: TACE ± Systemic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a diagnosis of HCC confirmed by radiology, histology, or cytology; Received at least 1 TACE treatment； Contrast-enhanced computed tomography (CECT) examination within 1 month before the first TACE treatment; Exclusion Criteria: Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) > 2; History of liver or spleen resection; Loss to follow-up; CECT image data was incomplete, unclear, or artifact occurred.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinically significant portal hypertension (CSPH) group<br>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. | Procedure: TACE ± Systemic therapy<br>* 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.<br>|
| non-CSPH group<br>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. | Procedure: TACE ± Systemic therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | The OS is defined as the time from the initiation of any treatment to death due to any cause. | up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per mRECIST. | up to approximately 2 years | 
| Progression free survival(PFS) per mRECIST | 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. | up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, transarterial chemoembolization, portal hypertension, non-invasive imaging assessment, deep learning