DEB-TACE Treatment in 367 Liver Cancer Patients

Study Overview
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Brief Summary
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Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. This study aimed to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer. Hypothesis:DEB-TACE illustrates a better treatment response, progression free survival (PFS), overall survival (OS) and less common adverse events (AEs) in liver cancer patients. Objective: to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.

Official Title
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The Comprehensive Analysis of Efficacy and Safety of CalliSpheres® Drug-eluting Beads Transarterial Chemoembolization in 367 Patients With Liver Cancer: a Multiple-center Cohort Study (CTILC Study)

Conditions
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Liver Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as primary HCC, primary ICC or secondary liver cancer confirmed by pathological findings, clinical features or radiographic examinations according to American Association for the Study of the Liver Diseases (AASLD) guidelines; Age above 18 years; About to receive DEB-TACE treatment with CalliSpheres® according to clinical needs and patients' willing. Able to be followed up regularly; Life expectancy above 12 months. Exclusion Criteria: History of liver transplantation; History of hematological malignances; Severe hepatic failure or renal failure; Contraindication for angiography, embolization procedure or artery puncture; Patients with cognitive impairment, or unable to understand the study consents. Women in gestation or lactation period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Treatment response was assessed at 1-3 months after DEB-TACE treatment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) by enhanced computerized tomography (CT) or magnetic resonance imaging (MRI) examination. | One-three months after DEB-TACE treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | OS was calculated from the time of DEB-TACE operation to the time of patient's death from any causes. | The median follow-up duration was 171 (range from 38 to 404) days. | 
| Liver function evaluation | Liver function indexes including ALB, TP, TBIL, TBA, ALT, AST and ALP were recorded before, 1 week post and 1-3 months post DEB-TACE treatment to evaluate the influence of DEB-TACE on liver function. The analysis of liver function evaluation was based on the treatment records of DEB-TACE . | One week post and 1-3 months post DEB-TACE treatment. | 
| Adverse events (AEs) | AEs were recorded during DEB-TACE operation and 1 month after DEB-TACE operation, and the analysis of AEs was based on the treatment records of DEB-TACE. | During DEB-TACE operation and 1 month after DEB-TACE operation. |