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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704192
• Other study ID #: CHANCE-CHESS 2302
• Status: Recruiting
• Start date: May 4, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Zhongda Hospital
• Contact: Gao-Jun Teng, M.D.
• Phone: +86-02583272121
• Email: gjteng[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 373
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

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.

Locations

Country	Name	City	State
China	Gao-Jun Teng	Nanjing
China	Xiaolong Qi	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Faitot F, Allard MA, Pittau G, Ciacio O, Adam R, Castaing D, Cunha AS, Pelletier G, Cherqui D, Samuel D, Vibert E. Impact of clinically evident portal hypertension on the course of hepatocellular carcinoma in patients listed for liver transplantation. Hepatology. 2015 Jul;62(1):179-87. doi: 10.1002/hep.27864. Epub 2015 May 20. — View Citation

Iranmanesh P, Vazquez O, Terraz S, Majno P, Spahr L, Poncet A, Morel P, Mentha G, Toso C. Accurate computed tomography-based portal pressure assessment in patients with hepatocellular carcinoma. J Hepatol. 2014 May;60(5):969-74. doi: 10.1016/j.jhep.2013.12.015. Epub 2013 Dec 19. — View Citation

Muller L, Hahn F, Mahringer-Kunz A, Stoehr F, Gairing SJ, Foerster F, Weinmann A, Galle PR, Mittler J, Pinto Dos Santos D, Pitton MB, Duber C, Fehrenbach U, Auer TA, Gebauer B, Kloeckner R. Prevalence and clinical significance of clinically evident portal hypertension in patients with hepatocellular carcinoma undergoing transarterial chemoembolization. United European Gastroenterol J. 2022 Feb;10(1):41-53. doi: 10.1002/ueg2.12188. Epub 2021 Dec 16. — View Citation

Yu Q, Huang Y, Li X, Pavlides M, Liu D, Luo H, Ding H, An W, Liu F, Zuo C, Lu C, Tang T, Wang Y, Huang S, Liu C, Zheng T, Kang N, Liu C, Wang J, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Fang Q, Fu CC, Zhang R, Wang C, Wei J, Tian J, Ormeci N, Ellik Z, Asiller OO, Ju S, Qi X. An imaging-based artificial intelligence model for non-invasive grading of hepatic venous pressure gradient in cirrhotic portal hypertension. Cell Rep Med. 2022 Mar 15;3(3):100563. doi: 10.1016/j.xcrm.2022.100563. eCollection 2022 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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