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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Ruijin Hospital | OTHER |
| Changhai Hospital | OTHER |
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-modal Precision Ablation | Experimental | In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-modal Precision Ablation | Device | In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xudong Qu, MD. PhD. | Contact | +86-021-64041990 | 5033 | qu.xudong@zs-hospital.sh.cn |
| Wentao Li, MD. PhD. | Contact | +86-021-64175590 | 83613 | liwentao98@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lisaxu Xu, MD. PhD. | Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16019852 | Result | Liu P, Zhang A, Xu Y, Xu LX. Study of non-uniform nanoparticle liposome extravasation in tumour. Int J Hyperthermia. 2005 May;21(3):259-70. doi: 10.1080/02656730500068643. | |
| 17110769 | Result | Zhang A, Xu LX, Sandison GA, Cheng S. Morphological study of endothelial cells during freezing. Phys Med Biol. 2006 Dec 7;51(23):6047-60. doi: 10.1088/0031-9155/51/23/007. Epub 2006 Nov 2. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
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| OTHER |
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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 |
| 18470620 | Result | Shen Y, Liu P, Zhang A, Xu LX. Study on tumor microvasculature damage induced by alternate cooling and heating. Ann Biomed Eng. 2008 Aug;36(8):1409-19. doi: 10.1007/s10439-008-9511-2. Epub 2008 May 10. |
| 19219697 | Result | Dong J, Liu P, Xu LX. Immunologic response induced by synergistic effect of alternating cooling and heating of breast cancer. Int J Hyperthermia. 2009 Feb;25(1):25-33. doi: 10.1080/02656730802279534. |
| 24732979 | Result | Bai JF, Liu P, Xu LX. Recent advances in thermal treatment techniques and thermally induced immune responses against cancer. IEEE Trans Biomed Eng. 2014 May;61(5):1497-505. doi: 10.1109/TBME.2014.2314357. Epub 2014 Apr 10. |
| 27162549 | Result | Xue T, Liu P, Zhou Y, Liu K, Yang L, Moritz RL, Yan W, Xu LX. Interleukin-6 Induced "Acute" Phenotypic Microenvironment Promotes Th1 Anti-Tumor Immunity in Cryo-Thermal Therapy Revealed By Shotgun and Parallel Reaction Monitoring Proteomics. Theranostics. 2016 Mar 21;6(6):773-94. doi: 10.7150/thno.14394. eCollection 2016. |
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |