Impact of Clinical Evident Portal Hypertension on HCC With TACE (CHANCE-CHESS 2301)
1 other identifier
observational
228
1 country
2
Brief Summary
The purpose of this study is to discuss the prognostic value of CEPH among HCC patients underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.
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)
CEPH group
CEPH was defined when at least one following factor was present: 1) esophageal/gastric varices on upper endoscopy or CT imaging, 2) ascites requiring diuretic treatment, 3) splenomegaly (largest diameter on CT \>12 cm) with a low platelet count (\<100,000/mm3).
non-CEPH group
Non-CEPH was defined when none of the following factor was present: 1) esophageal/gastric varices on upper endoscopy or CT imaging, 2) ascites requiring diuretic treatment, 3) splenomegaly (largest diameter on CT \>12 cm) with a low platelet count (\<100,000/mm3).
Interventions
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); Systemic therapy: PD-1/PD-L1 inhibitors, 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 June 2006 to December 2021.
You may qualify if:
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Received at least 1 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;
- ECOG Performance Score \> 2;
- History of spleen resection;
- Loss to follow-up.
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)
Hernandez-Gea V, Turon F, Berzigotti A, Villanueva A. Management of small hepatocellular carcinoma in cirrhosis: focus on portal hypertension. World J Gastroenterol. 2013 Feb 28;19(8):1193-9. doi: 10.3748/wjg.v19.i8.1193.
PMID: 23482437BACKGROUNDMuller 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: 34918471BACKGROUNDFaitot 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: 25914217BACKGROUNDEuropean Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.
PMID: 22424438BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gao-Jun Teng, M.D.
Zhongda hospital, Southeast university, Nanjing, China
- PRINCIPAL INVESTIGATOR
Xiaolong Qi, M.D.
Zhongda hospital, 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