CT-based HVPG Assessment for Predicting the Prognosis of HCC With TACE (CHANCE-CHESS 2302)

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

Non-invasive CT-based Hepatic Venous Pressure Gradient Assessment for Predicting the Prognosis of Hepatocellular Carcinoma With Transarterial Chemoembolization (CHANCE-CHESS 2302): A Multicenter Retrospective Study

This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).

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. Portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with HCC. Clinically significant portal hypertension is defined as >10 mmHg increase in the hepatic vein pressure gradient (HVPG), and the current gold standard for its assessment is direct measurement, through a transjugular approach. However, due to its invasive character and high effort, HVPG measurement is not a standard tool in the initial diagnostic evaluation of patients with HCC. This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).

Study Type

Observational

Enrollment (Estimated)

373

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 January 2010 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；
  3. Contrast-enhanced computed tomography (CECT) examination within 1 month before the first TACE treatment;

Exclusion Criteria:

  1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  2. Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) > 2;
  3. History of liver or spleen resection;
  4. Loss to follow-up;
  5. CECT image data was incomplete, unclear, or artifact occurred.

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
non-CSPH group
A CT-based HVPG Score, whose computed formula was: 17.37-4.91*ln(Liver/Spleen volume ratio) +3.8[If presence of peri-hepatic ascites],was used to diagnose CSPH (HVPG>10mmHg) with a cut-off value 11.606.
Procedure: TACE ± Systemic therapy
TACE: conventional TACE (cTACE) or drug-eluting beads TACE (dTACE); Systemic therapy: programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) inhibitors, vascular endothelial growth factor -tyrosine kinase inhibitor (VEGF-TKI)/bevacizumab, PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, radiotherapy or chemotherapy.
Clinically significant portal hypertension (CSPH) group
A CT-based HVPG Score, whose computed formula was: 17.37-4.91*ln(Liver/Spleen volume ratio) +3.8[If presence of peri-hepatic ascites],was used to diagnose CSPH (HVPG>10mmHg) with a cut-off value 11.606.
Procedure: TACE ± Systemic therapy
TACE: conventional TACE (cTACE) or drug-eluting beads TACE (dTACE); Systemic therapy: programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) inhibitors, vascular endothelial growth factor -tyrosine kinase inhibitor (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, Zhongda hospital, Southeast university, Nanjing, China
  • Principal Investigator: Xiaolong Qi, M.D., Zhongda Hospital, Medical School, 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 2302

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.

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