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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03317483
Other study ID # CTILC
Secondary ID
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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.
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