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

Recruiting

• Conditions: Portal Hypertension; Hepatocellular Carcinoma
• Interventions: Procedure: TACE ± Systemic therapy

• Registration Number: NCT05703750
• Lead Sponsor: Zhongda Hospital

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.

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. 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.

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Status Verified: 2023-05
• Study Start: 2023-05-04
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-CEPH group	TACE ± Systemic therapy	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).
CEPH group	TACE ± Systemic therapy	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Gao-Jun Teng; 🇨🇳 Nanjing, China

Xiaolong Qi; 🇨🇳 Nanjing, China