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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-04

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

TACE ± Systemic therapy

Intervention Type PROCEDURE

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.

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).

TACE ± Systemic therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No