DEB-TACE Treatment in 367 Liver Cancer Patients

Liver Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317483
• Other study ID #: CTILC
• Status: Completed
• Phase: N/A
• First received: October 13, 2017
• Last updated: October 19, 2017
• Start date: November 12, 2015
• Est. completion date: December 28, 2016

Study information

• Verified date: October 2017
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: December 28, 2016
• Est. primary completion date: November 4, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.