This study will document for the safety and efficacy of image guided multi-mode precision ablation system (the combination of cryoablation and radiofrequency ablation) for the treatment of liver malignant, as well as provide the indicator of antitumor immune response for liver malignant in China.
Either Cryoablation or Radiofrequency Ablation has been well accepted and widely used in clinical practice for solid tumor treatments with various commercial systems. Previous studies have established that locally exerting great thermal and mechanical stress through alternating freezing and heating abruptly broke the tumor cells and micro-vasculature in situ, enabling complete damage of primary tumor. Large amount of biological stimuli was released during this process to enhance body anti-tumor immunological response. This method thus may inhibit distal metastases and increase the survival rate. The investigators hypothesized that multi-mode thermal method (the combination of cryoablation, radiofrequency ablation) might trigger a whole body anti-tumor immune response for malignant tumor basing on multi-scale bio-thermal responses at molecular, cellular, tumor angiogenesis and tissue levels. The purpose of this study was to prospectively investigate the safety and feasibility of multi-mode precision ablation system for the treatment of liver malignant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGLocal control rate
Contrast enhanced CT or MRI was performed to evaluate Local tumor control
Time frame: From date of randomization until the date of progression of ablation lesion, assessed up to 5 years.
Overall survival (OS)
Overall survival is defined as the time (in months) from the date of randomization to the death date.
Time frame: From date of randomization until the date of death, assessed up to 5 years.
Progression free survival (PFS)
Progression-free survival is defined as the time (in months) from the date of randomization until the date of the Investigator-assessed radiological disease progression or death due to any cause.
Time frame: From date of randomization until the date of first documented progression, recurrence or date of death from any cause, whichever came first first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Complication rate
Number of participants with adverse events and complication
Time frame: 6 months
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