Standardization of Multi-modal Tumor Ablation Therapy System

NCT ID: NCT03223142

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2020-07-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-modal Precision Ablation

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

Group Type: EXPERIMENTAL

Multi-modal Precision Ablation

Intervention Type: DEVICE

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

Interventions

Multi-modal Precision Ablation

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

Intervention Type: DEVICE

Other Intervention Names

cryoablation; radiofrequency ablation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisaxu Xu, MD. PhD.

Role: STUDY_CHAIR

Shanghai Jiao Tong University School of Medicine

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xudong Qu, MD. PhD.

Role: CONTACT

qu.xudong@zs-hospital.sh.cn

+86-021-64041990 ext. 5033

Wentao Li, MD. PhD.

Role: CONTACT

liwentao98@126.com

+86-021-64175590 ext. 83613

Facility Contacts

Wentao Li, MD. PhD

Role: primary

liwentao98@126.com

+86-021-64175590 ext. 83613

References

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.

Reference Type: RESULT

PMID: 16019852 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17110769 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18470620 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19219697 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24732979 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27162549 (View on PubMed)

Other Identifiers

1604159-3-1605&1604159-3-1606

Identifier Type: -

Identifier Source: org_study_id