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

May 29, 2023 updated by: Gao-jun Teng, Zhongda Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Gao-Jun Teng
        • Contact:
          • Yu-Qing Wang
      • Nanjing, China
        • Recruiting
        • Xiaolong Qi
        • Contact:
          • Yu-Qing Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with HCC treated with TACE ± Systemic Treatment from June 2006 to December 2021.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: up to approximately 2 years
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)
Time Frame: 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.
up to approximately 2 years
Progression free survival(PFS) per mRECIST
Time Frame: 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.
up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Estimated)

June 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANCE-CHESS 2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on TACE ± Systemic therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe