DEB-TACE Treatment in 367 Liver Cancer Patients

NCT03317483 | Completed

• 1 other identifier: CTILC
• Study Type: observational
• Target: 367
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• overall survival

  The median follow-up duration was 171 (range from 38 to 404) days.

• Liver function evaluation

  One week post and 1-3 months post DEB-TACE treatment.

• Adverse events (AEs)

  During DEB-TACE operation and 1 month after DEB-TACE operation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Related Publications (1)

• Luo J, Zheng J, Shi C, Fang J, Peng Z, Huang J, Sun J, Zhou G, Li T, Zhu D, Xu H, Hou Q, Ying S, Sun Z, Du H, Xie X, Cao G, Ji W, Han J, Gu W, Guo X, Shao G, Yu Z, Zhou J, Yu W, Zhang X, Li L, Hu H, Hu T, Wu X, Chen Y, Ji J, Hu W. Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients: A preliminary result from CTILC study. Medicine (Baltimore). 2020 Mar;99(12):e19276. doi: 10.1097/MD.0000000000019276.

  PMID: 32195932 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 404 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Zhejiang Cancer Hospital

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 23, 2017
• Study Start: November 12, 2015
• Primary Completion: November 4, 2016
• Study Completion: December 28, 2016
• Last Updated: October 23, 2017

Record last verified: 2017-10