Clinical trial NCT03317483: DEB-TACE Treatment in 367 Liver Cancer Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Treatment response
timeFrame: One-three months after DEB-TACE treatment
Secondary outcomes:
measure: overall survival
timeFrame: The median follow-up duration was 171 (range from 38 to 404) days.
measure: Liver function evaluation
timeFrame: One week post and 1-3 months post DEB-TACE treatment.
measure: Adverse events (AEs)
timeFrame: During DEB-TACE operation and 1 month after DEB-TACE operation.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.