DEB-TACE Treatment in 367 Liver Cancer Patients
|ClinicalTrials.gov Identifier: NCT03317483|
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||367 participants|
|Target Follow-Up Duration:||404 Days|
|Official Title:||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)|
|Actual Study Start Date :||November 12, 2015|
|Actual Primary Completion Date :||November 4, 2016|
|Actual Study Completion Date :||December 28, 2016|
- Treatment response [ Time Frame: One-three months after DEB-TACE treatment ]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.
- overall survival [ Time Frame: The median follow-up duration was 171 (range from 38 to 404) days. ]OS was calculated from the time of DEB-TACE operation to the time of patient's death from any causes.
- Liver function evaluation [ Time Frame: One week post and 1-3 months post DEB-TACE treatment. ]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 .
- Adverse events (AEs) [ Time Frame: During DEB-TACE operation and 1 month after DEB-TACE operation. ]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.