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Standardization of Multi-modal Tumor Ablation Therapy System (SMTATS)

Primary Purpose

Liver Neoplasms, Ablation Techniques, Cryoablation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Multi-modal Precision Ablation

About this trial

This is an interventional treatment trial for Liver Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi-modal Precision Ablation

Arm Description

In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation

Outcomes

Primary Outcome Measures

Local control rate

Contrast enhanced CT or MRI was performed to evaluate Local tumor control

Secondary Outcome Measures

Overall survival (OS)

Overall survival is defined as the time (in months) from the date of randomization to the death date.

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.

Complication rate

Number of participants with adverse events and complication

Full Information

NCT ID

NCT03223142

First Posted

July 17, 2017

Last Updated

July 17, 2017

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Fudan University, Ruijin Hospital, Changhai Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03223142

Brief Title

Standardization of Multi-modal Tumor Ablation Therapy System

Acronym

SMTATS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2017 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

Collaborators

Fudan University, Ruijin Hospital, Changhai Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multi-modal Precision Ablation

Arm Type

Experimental

Arm Description

In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation

Intervention Type

Device

Intervention Name(s)

Multi-modal Precision Ablation

Other Intervention Name(s)

cryoablation, radiofrequency ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Local control rate

Description

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.

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

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.

Title

Progression free survival (PFS)

Description

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.

Title

Complication rate

Description

Number of participants with adverse events and complication

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xudong Qu, MD. PhD.

Phone

+86-021-64041990

Ext

5033

qu.xudong@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wentao Li, MD. PhD.

Phone

+86-021-64175590

Ext

83613

liwentao98@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisaxu Xu, MD. PhD.

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wentao Li, MD. PhD

Phone

+86-021-64175590

Ext

83613

liwentao98@126.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

16019852

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. doi: 10.1080/02656730500068643.

Results Reference

result

PubMed Identifier

17110769

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. doi: 10.1088/0031-9155/51/23/007. Epub 2006 Nov 2.

Results Reference

result

PubMed Identifier

18470620

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.

Results Reference

result

PubMed Identifier

19219697

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.

Results Reference

result

PubMed Identifier

24732979

Citation

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.

Results Reference

result

PubMed Identifier

27162549

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. 2016 Mar 21;6(6):773-94. doi: 10.7150/thno.14394. eCollection 2016.

Results Reference

result

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Standardization of Multi-modal Tumor Ablation Therapy System

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