A Phase 3 interventional study of Thermal Ablation and EADM in Carcinoma, Hepatocellular, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-18.
Sponsored by Shanghai Zhongshan Hospital · Phase 3, Interventional, and Treatment
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 280 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Procedure: Thermal Ablation · Drug: EADM · Drug: Ultra-fluid lipiodol · Other: Gelatin sponge articles
Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Drug: EADM · Drug: Ultra-fluid lipiodol · Other: Gelatin sponge articles
Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
Also known as: Radiofrequency ablation, Microwave ablation
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Also known as: Epirubicin
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Also known as: lipiodol
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Overall Survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 26 months
Time-to-Disease Progression
TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression.
Time frame: From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months
Objective response rate (ORR)
The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST)
Time frame: Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.
Progression free survival(PFS)
Time frame: From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.
Numbers of TACE and TACE combined with ablation cycles
The times of the subjects undergoing TACE or TACE combined with ablation
Time frame: From the date of randomization until the date of death, assessed up to 26 months.
Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups
Serious or mild adverse events after treatment
Time frame: From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation)
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital