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

Sponsor

Zhongda Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05703750

Collaborator

(none)

228

Enrollment

Locations

10.9

Anticipated Duration (Months)

114

Patients Per Site

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Portal Hypertension	Procedure: TACE ± Systemic therapy

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 Design

Study Type:

Observational

Anticipated Enrollment :

228 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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).	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.
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).	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.

Arm

Intervention/Treatment

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).

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.

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).

Procedure: TACE ± Systemic therapy

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gao-Jun Teng	Nanjing		China
2	Xiaolong Qi	Nanjing		China

Sponsors and Collaborators

Zhongda Hospital

Investigators

Principal Investigator: Gao-Jun Teng, M.D., Zhongda hospital, Southeast university, Nanjing, China
Principal Investigator: Xiaolong Qi, M.D., Zhongda hospital, Southeast university, Nanjing, China