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NCT Number: NCT03317483

DEB-TACE Treatment in 367 Liver Cancer Patients

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2017
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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