Standardization of Multi-modal Tumor Ablation Therapy System

Neoplasm Metastasis Clinical Trial

— SMTATS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03223142
• Other study ID #: 1604159-3-1605&1604159-3-1606
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 17, 2017
• Start date: July 2017
• Est. completion date: July 2020

Study information

• Verified date: September 2016
• Source: Shanghai Zhongshan Hospital
• Contact: Xudong Qu, MD. PhD.
• Phone: +86-021-64041990
• Email: qu.xudong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Multi-modal Precision Ablation
In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Changhai Hospital, Fudan University, Ruijin Hospital, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Nov 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Complication rate	Number of participants with adverse events and complication	6 months