Clinical trial · Observational

DEB-TACE Treatment in 367 Liver Cancer Patients

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)

NCT03317483CI-TRIAL-00030010completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Treatment response
timeFrame
One-three months after DEB-TACE treatment
description
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 (3)

measure
overall survival
timeFrame
The median follow-up duration was 171 (range from 38 to 404) days.
description
OS was calculated from the time of DEB-TACE operation to the time of patient's death from any causes.
measure
Liver function evaluation
timeFrame
One week post and 1-3 months post DEB-TACE treatment.
description
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 .

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDLuo 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