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Trial Title:
Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)
NCT ID:
NCT05543304
Condition:
Hepatocellular Carcinoma Non-resectable
Effect of Drug
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
systemic therapy
immunotherapy
tyrosine kinase inhibitor
treatment response
radiomics
clinical characteristics
machine learning
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
radiological evaluation
Description:
All patients with advanced HCC receive imaging evaluation before and after systemic
treatments to assess the development of diseases.
Arm group label:
patients with no response to systemic therapies
Arm group label:
patients with response to systemic therapies
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.
Criteria for eligibility:
Study pop:
Patients with unresectable HCC who received systemic therapies.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gang Chen
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Start date:
December 1, 2018
Completion date:
December 1, 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Agency class:
Other
Collaborator:
Agency:
Eastern Hepatobiliary Surgery Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
First Affiliated Hospital of Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05543304
