Clinical trial · Interventional
Standardization of Multi-modal Tumor Ablation Therapy System
A Pilot Study of Multi-mode Precision Ablation System for the Treatment of Liver Malignant
NCT03223142CI-TRIAL-00028704SMTATSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ablation Techniques | — | UNRESOLVED | — |
| Clinical Trial | — | UNRESOLVED | — |
| Cryoablation | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Safety | — | UNRESOLVED | — |
| Treatment Outcome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-modal Precision Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-modal Precision Ablation
- description
- In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation
- interventionNames
- Device: Multi-modal Precision Ablation
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- From date of randomization until the date of progression of ablation lesion, assessed up to 5 years.
- description
- Contrast enhanced CT or MRI was performed to evaluate Local tumor control
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- From date of randomization until the date of death, assessed up to 5 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (6)
- RESULTLiu 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. PMID 16019852
- RESULTZhang 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. PMID 17110769
- RESULTShen 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. PMID 18470620
- RESULTDong 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. PMID 19219697
- RESULTBai 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. PMID 24732979
- RESULTXue 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. PMID 27162549