DEB-TACE Treatment in 367 Liver Cancer Patients

Zhejiang Cancer Hospital367 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

367

Conditions

Liver Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: One-three months after DEB-TACE treatment

Secondary Outcomes

overall survival

OS was calculated from the time of DEB-TACE operation to the time of patient's death from any causes.

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

Liver function evaluation

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 .

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

Adverse events (AEs)

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.

Time frame: During DEB-TACE operation and 1 month after DEB-TACE operation.