DEB-TACE Treatment in 367 Liver Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-12

Study Completion Date

2016-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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guoliang shao

Vice president of Zhejiang Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED

PMID: 32195932 (View on PubMed)

Other Identifiers

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CTILC

Identifier Type: -

Identifier Source: org_study_id