Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers (CHANCEsub)

March 4, 2022 updated by: Gao-jun Teng, Zhongda Hospital

Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers

The purpose of this study is to id

transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital, Southeast University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gao-Jun Teng, MD

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with intermediate HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions.

Description

Inclusion Criteria:

  1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
  2. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
  3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
  4. TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
  5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；

7. Has repeated measurable intrahepatic lesions according to RECIST v1.1;

Exclusion Criteria:

  1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  2. Unable to meet criteria of combination timeframe described above;
  3. Missing follow-up data;

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

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 combination treatment to death due to any cause.
up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: baseline
The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
baseline
Sensitivity
Time Frame: baseline
The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode
Time Frame: baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
baseline
Accuracy
Time Frame: baseline
Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.
baseline

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

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 (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANCE-Biomarker

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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