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Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05543304
Enrollment
200
Registered
2022-09-16
Start date
2018-12-01
Completion date
2024-12-01
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Drug, Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular Carcinoma, systemic therapy, immunotherapy, tyrosine kinase inhibitor, treatment response, radiomics, clinical characteristics, machine learning

Brief 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.

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.

Interventions

All patients with advanced HCC receive imaging evaluation before and after systemic treatments to assess the development of diseases.

Sponsors

First Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER
The First Affiliated Hospital of Zhejiang Chinese Medical University
CollaboratorOTHER
Eastern Hepatobiliary Surgery Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective response rate3 monthsTumor response are evaluated to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).

Secondary

MeasureTime frameDescription
Overall survival1 yearOverall survival was defined as the time from treatment to death for any reason.
Progression free survival1 yearProgression free survival was defined as the time from treatment to first progression or death.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026