CT-based HVPG Assessment for Predicting the Prognosis of HCC With TACE (CHANCE-CHESS 2302)
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
1 other identifier
observational
373
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
May 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 31, 2023
May 1, 2023
2 months
January 19, 2023
May 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Objective response rate(ORR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
up to approximately 2 years
Progression free survival(PFS) per mRECIST
up to approximately 2 years
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
Patients with HCC treated with TACE ± Systemic Treatment from January 2010 to December 2021.
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (2)
Gao-Jun Teng
Nanjing, China
Xiaolong Qi
Nanjing, China
Related Publications (4)
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.
PMID: 34918471BACKGROUNDIranmanesh 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.
PMID: 24362073BACKGROUNDYu 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.
PMID: 35492878BACKGROUNDFaitot 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.
PMID: 25914217BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
May 4, 2023
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share