To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group,with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Thermosensitive Nanogel Embolic Agent
Gao-Jun Teng
Nanjing, China
RECRUITINGDisease control rate (DCR)
Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
Time frame: One month after the last TACE
Success rate of target lesion embolization
Success rate of target lesion embolization, evaluated by the investigator and independent image review committee respectively.
Time frame: One month after the last TACE
Objective response rate (ORR)
Objective response rate of target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST).
Time frame: One month after the last TACE treatment
Disease control rate (DCR)
Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
Time frame: Three and six months after the first TACE
Equipment performance evaluation
(Intraoperative imaging ability, microcatheter delivery capacity) evaluated by the investigator.
Time frame: One month after the first TACE
Adverse events
Rate of adverse events, evaluated by the investigator (CTACE 5.0)
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.