DEB-TACE Treatment in 367 Liver Cancer Patients

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03317483

Enrollment

367

Registered

2017-10-23

Start date

2015-11-12

Completion date

2016-12-28

Last updated

2017-10-23

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

Conditions

Liver Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

1. 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; 2. Age above 18 years; 3. About to receive DEB-TACE treatment with CalliSpheres® according to clinical needs and patients' willing. 4. Able to be followed up regularly; 5. Life expectancy above 12 months.

Exclusion criteria

1. History of liver transplantation; 2. History of hematological malignances; 3. Severe hepatic failure or renal failure; 4. Contraindication for angiography, embolization procedure or artery puncture; 5. Patients with cognitive impairment, or unable to understand the study consents. 6. Women in gestation or lactation period.

Design outcomes

Primary

Measure	Time frame	Description
Treatment response	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.

Secondary

Measure	Time frame	Description
overall survival	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	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)	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.

Outcome results