TACE With Thermosensitive Nanogel Versus Embosphere for HCC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhongda Hospital
About this trial
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
Liver function status: Child-Pugh A or B
Eastern Cooperative Oncology Group score: 0-2 points;
With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
Disqualifiers
The target lesion has been embolized before or require combined with other treatment(s);
Diffuse or with extrahepatic metastasis;
Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
Severe renal dysfunctions (creatinine clearance rate <30 ml/min);
Trial design
Design model
Parallel
Treatments tested in this trial
Thermosensitive Nanogel Embolic Agent
DeviceThermosensitive Nanogel Embolic Agent
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: TACE with Thermosensitive Nanogel Embolic AgentExperimental treatment 1 intervention
Group B: TACE with Embosphere MicrospheresActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disease 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 TACESecondary outcomes
1
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 TACE2
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 treatment3
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 TACE4
Equipment performance evaluation
(Intraoperative imaging ability, microcatheter delivery capacity) evaluated by the investigator.
Time frame
One month after the first TACESponsors and contacts
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Source ClinicalTrials.gov