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DEB-TACE Treatment in 367 Liver Cancer Patients

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ClinicalTrials.gov Identifier: NCT03317483
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
guoliang shao, Zhejiang Cancer Hospital

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.


Condition or disease
Liver Cancer

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Study Type : Observational [Patient Registry]
Actual Enrollment : 367 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 .

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
367 liver cancer patients about to receive DEB-TACE treatment from 2015/11/12 to 2016/11/04 were prospectively included in CTILC study.
Criteria

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.

Additional Information:

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Responsible Party: guoliang shao, Vice president of Zhejiang Cancer Hospital, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03317483     History of Changes
Other Study ID Numbers: CTILC
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases