this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
344
Patients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response.
Patients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response.
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China
Objective response rate
the percentage of patients who achieved complete response (CR) and partial response (PR) as the best response, according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria
Time frame: Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year
Overall survival
Overall survival (OS) is measured from the treatment start until all-cause death or the last follow-up date
Time frame: The last patient has been on study for 1year
Time to progression
Time to progression is measured from the treatment start to the radiologically confirmed progression
Time frame: The last patient has been on study for 1year
Adverse event
The terms and grade of adverse event will be present according to the Common Terminology Criteria for Adverse Event (CTCAE version 4.0)
Time frame: The adverse event will be assessed during in hospital and every 4 weeks, up to 1year
Progression-free survival
Progression-free survival (PFS) is measured from the treatment start until all-cause death or untreatable progression (vascular invasion, extra hepatic spread, the Eastern Cooperative Oncology Group (ECOG) performance status \>2, and Child-Pugh grade over C, but except hepatic new nodule)
Time frame: The last patient has been on study for 1year
Time to response
Time to response (TTR) is measured from the treatment start to the firstly radiologically confirmed complete response or partial response.
Time frame: The last patient has been on study for 1year
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Duration of response
Duration of response (DOR) is measured from the first-time confirmed complete response or partial response to the date of radiological progression
Time frame: The last patient has been on study for 1year