Standardization of Multi-modal Tumor Ablation Therapy System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Multi-mode Precision Ablation System for the Treatment of Liver Malignant

Conditions
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Liver Neoplasms, Ablation Techniques, Cryoablation, Safety, Treatment Outcome, Neoplasm Metastasis, Clinical Trial

Intervention / Treatment
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* Device: Multi-modal Precision Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Adults aged 18 years to 70 years of either gender; 2. Histologically/cytologically confirmed hepatocellular carcinoma or colorectal cancer with liver metastasis, the primary lesion had underwent radical resection and without local recurrent, extrahepatic metastasis; 3. At least one measurable liver metastasis by RECIST criteria. No more than 5 lesions and smaller than 4.0 cm each; 4. Patients' liver function classified as Child-Pugh A or B, total bilirubin <=3.0 mg/dL, serum creatinine <= 2.5 mg/dL, White blood cell count >= 2.0×10^9/L, Platelets >= 100×10^9/L; 5. Performance Status(PS): Eastern cooperative Oncology Group (ECOG) <= 2, and life expectancy longer than three months; 6. Prior therapy, e.g., chemotherapy, radiation, is allowed provided that more than one month washout time is given, and recover from the previous treatment: according to the Common Terminology Criteria Adverse Events (CTC AE) version 4.0, all side effects (except for hair loss) degrading to 1 level or lower. Exclusion Criteria: 1. Child-Pugh grade Class C, or tumor invasion into the portal vein; 2. Patient underwent previous cryoablation or other thermal ablation; 3. Patient underwent prior therapy, e.g., chemotherapy, radiation,or other anti-cancer medication no more than 3 weeks; 4. Patients with severe disorders of heart, lung, liver, kidney function or irreversible coagulation disorder; 5. Patients combined with other uncontrolled disease, including but not limited to: hypertension or diabetes, active infection, or mental illness or social condition that may affect the subject's compliance; 6. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-modal Precision Ablation<br>In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation | Device: Multi-modal Precision Ablation<br>* In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation<br>* Other names: radiofrequency ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | Contrast enhanced CT or MRI was performed to evaluate Local tumor control | From date of randomization until the date of progression of ablation lesion, assessed up to 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Overall survival is defined as the time (in months) from the date of randomization to the death date. | 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. | 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 | 6 months |