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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Carcinoma, Portal Hypertension

Intervention / Treatment
-----------------
* Procedure: TACE ± Systemic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a diagnosis of HCC confirmed by radiology, histology, or cytology; Received at least 1 TACE treatment； Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CEPH group<br>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). | Procedure: TACE ± Systemic therapy<br>* 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.<br>|
| non-CEPH group<br>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). | Procedure: TACE ± Systemic therapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, transarterial chemoembolization, clinical evident portal hypertension