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

Southeast University

Status: Enrolling

Conditions: Portal Hypertension; Hepatocellular Carcinoma

Treatments: Procedure: TACE ± Systemic therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05703750

CHANCE-CHESS 2301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

228 participants in 2 patient groups

CEPH group

Description:

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).

Treatment:

Procedure: TACE ± Systemic therapy

non-CEPH group

Description:

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).

Treatment:

Procedure: TACE ± Systemic therapy