This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond University of California, San Francisco (UCSF) criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
Drug-eluting beads transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization
Drug-eluting beads
Beijing Tsinghua Chang Gung Hospital
Beijing, China
RECRUITINGDownstaging success rate
Criteria for success rate in downstaging meet UCSF criteria or the standard for liver resection.
Time frame: Within 6 months after surgery
Complete response (CR)
Disappearance of any intratumoral arterial enhancement in all target lesions
Time frame: 1, 3, 6 months after surgery
Partial response (PR)
At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions
Time frame: 1, 3, 6 months after surgery
Stable disease (SD)
Number of the subjects that do not qualify for partial response or progressive disease measured by modified Response Evaluation Criteria in Solid Tumors( mRECIST) criteria
Time frame: up to 6months after TACE procedure
Progressive disease (PD)
An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started
Time frame: 1, 3, 6 months after surgery
Objective response (OR)
CR+PR
Time frame: 1, 3, 6 months after surgery
Duration of downstaging
Interval between initial TACE treatment and the success or failure of downstaging according to the UCSF criteria assessed by the dynamic enhanced CT ;
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Chemotherapy drug for intra-arterial infusion
Time frame: within 36 months
Times of TACE treatments
Times of TACE surgery
Time frame: within 36 months
Changes of tumor biomarkers (AFP, PIVKA-Ⅱ)
AFP and PIVKA-II must be measured at 1week before, 1 week,1month after TACE or curative treatment; AFP ,PIVKA-II could be measured every 3-6 months during follow up according to the availability of equipment at the site
Time frame: From 7 days before TACE or curative treatments to the endpoints of the trial.(Up to 36 months)
Changes in liver function
Changes of the Child-pugh Score that used to assess the prognosis of chronic liver disease,consisting of 5 items(ascites,total bilirubin,albumin,prothrombin time and degree of encephalopathy),of which is scored 1-3 points,with 3 indicating greatest severity)
Time frame: from the date of the first TACE to the end of the clinical trial or the death of the patient,Up to 36months
Tumor-free survival (TFS)
as the time from surgery initiation to tumor recurrence or death from any cause
Time frame: Within 36 months
Progression-free survival (PFS)
as the time from surgery initiation to disease progression or death from any cause
Time frame: Within 36 months
Overall survival (OS)
as the time from surgery initiation to death from any cause
Time frame: Within 36 months
Recurrence rate of Hepatocellular carcinoma
Recurrence rate of hepatocellular carcinoma
Time frame: Within 36 months