Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)

February 9, 2023 updated by: Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University

Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC) Based on Clinical Variables and Radiomics Data With Machine Learning Methods

As the most common type of primary liver cancer, hepatocellular carcinoma (HCC) has become a big challenge all over the world. Most patients are not available to curative resection when first diagnosed. There are a variety of treatment options for advanced HCC. However, due to the heterogeneity of HCC, the overall response rate (ORR) is not high for systemic therapies. Therefore, appropriate selection of patients who are suitable for individual systemic therapies is important for clinical decision-making.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Although major achievements have been acquired in diagnosis and treatment, the prognosis of hepatocellular carcinoma (HCC) is still unsatisfactory. Liver resection remains the main curative treatment for HCC, but most patients are at an advanced stage when first diagnosed, leading to be not available to curative therapies. There is a variety of treatment options for advanced HCC, such as transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), targeted therapy (sorafenib and lenvatinib), immunotherapy, and the combination of different therapies. However, due to the heterogeneity of HCC, different patients respond differently to systemic therapies. The the overall response rate (ORR) is not satisfactory and most patients can not benefit from the systemic therapies. There is an urgent need to identify patients who are likely to have positive response to systemic therapies at the beginning before treatment. Therefore ,we want to collect the clinical information of patients with advanced HCC treated with systemic therapies, including demographic data , laboratory index, histological features, radiomics data. Patients are followed-up at a interval of 1 month after treatment, and the ORR, overall survival (OS), progression-free survival (PFS) are recorded. Then the treatment response are evaluated and the relationship between the clinical data and efficacy of systemic therapies are explored by machine learning methods. Then models based on clinical features or radiomics features are developed to predict response to different systemic therapies.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Gang Chen

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with unresectable HCC who received systemic therapies.

Description

Inclusion Criteria:

  • clinically or pathologically diagnosed HCC
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
  • Child-Pugh score of ≤7
  • complete clinical and follow-up information
  • evaluable efficacy after treatment
  • age between 18-80 years old

Exclusion Criteria:

  • with other malignancies
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) >2
  • Child-Pugh score of >7
  • incomplete clinical data
  • lost to follow up
  • unevaluable efficacy after treatment
  • age <18 years old or >80 years old

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with response to systemic therapies
Patients shown complete response (CR) and partial response (PR) after treatments. The clinical data and radiomics data are collected through electronic medical record system.
Diagnostic test: radiological evaluation
All patients with advanced HCC receive imaging evaluation before and after systemic treatments to assess the development of diseases.
patients with no response to systemic therapies
Patients shown progressive disease (PD) and stable disease (SD) after treatments. The clinical data and radiomics data are collected through electronic medical record system.
Diagnostic test: radiological evaluation
All patients with advanced HCC receive imaging evaluation before and after systemic treatments to assess the development of diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 3 months
Tumor response are evaluated to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
Overall survival was defined as the time from treatment to death for any reason.
1 year
Progression free survival
Time Frame: 1 year
Progression free survival was defined as the time from treatment to first progression or death.
1 year

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

Qilu Hospital of Shandong University
Eastern Hepatobiliary Surgery Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University

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)

December 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (ACTUAL)

September 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • efficacy of systemic therapies

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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