Impact of Clinical Evident Portal Hypertension on HCC With TACE (CHANCE-CHESS 2301)

Hepatocellular Carcinoma Clinical Trial

Official title:

Impact of Clinical Evident Portal Hypertension on Hepatocellular Carcinoma With Transarterial Chemoembolization (CHANCE-CHESS 2301): A Multicenter Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703750
• Other study ID #: CHANCE-CHESS 2301
• 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

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.

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. Clinically relevant portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with HCC. The purpose of this study is to discuss the prognostic value of CEPH among HCC patients who underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• 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;

Exclusion Criteria:

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;

2. ECOG Performance Score > 2;

3. History of spleen resection;

4. Loss to follow-up.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• TACE ± Systemic therapy
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.

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)

European 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. Erratum In: J Hepatol. 2012 Jun;56(6):1430. — View Citation

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

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. — 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

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