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

Sponsor

Zhongda Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05704192

Collaborator

(none)

373

Enrollment

Locations

10.9

Anticipated Duration (Months)

186.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Portal Hypertension	Procedure: TACE ± Systemic therapy

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 Design

Study Type:

Observational

Anticipated Enrollment :

373 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Clinically significant portal hypertension (CSPH) group 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 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.
non-CSPH group 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 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

Intervention/Treatment

Clinically significant portal hypertension (CSPH) group

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

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.

non-CSPH group

Procedure: TACE ± Systemic therapy

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gao-Jun Teng	Nanjing		China
2	Xiaolong Qi	Nanjing		China

Sponsors and Collaborators

Zhongda Hospital

Investigators

Principal Investigator: Gao-Jun Teng, Zhongda hospital, Southeast university, Nanjing, China
Principal Investigator: Xiaolong Qi, M.D., Zhongda Hospital, Medical School, Southeast University, Nanjing, China