Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)

Last updated: February 9, 2023
Sponsor: First Affiliated Hospital of Wenzhou Medical University
Overall Status: Active - Enrolling

Phase

N/A

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05543304
efficacy of systemic therapies
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 200
Study Start date:
December 01, 2018
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Gang Chen

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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