Standardization of Multi-modal Tumor Ablation Therapy System

NCT03223142 | Unknown DMC

• 1 other identifier: 1604159-3-1605&1604159-3-1606
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  From date of randomization until the date of death, assessed up to 5 years.

• Progression free survival (PFS)

  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

  6 months

Study Arms (1)

Multi-modal Precision Ablation

EXPERIMENTAL

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

Device: Multi-modal Precision Ablation

Interventions

Multi-modal Precision Ablation DEVICE

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

Also known as: cryoablation, radiofrequency ablation

Multi-modal Precision Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years to 70 years of either gender;
• \. Histologically/cytologically confirmed hepatocellular carcinoma or colorectal cancer with liver metastasis, the primary lesion had underwent radical resection and without local recurrent, extrahepatic metastasis;
• \. At least one measurable liver metastasis by RECIST criteria. No more than 5 lesions and smaller than 4.0 cm each;
• \. 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;
• \. Performance Status(PS): Eastern cooperative Oncology Group (ECOG) \<= 2, and life expectancy longer than three months;
• \. 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.

You may not qualify if:

• \. Child-Pugh grade Class C, or tumor invasion into the portal vein;
• \. Patient underwent previous cryoablation or other thermal ablation;
• \. Patient underwent prior therapy, e.g., chemotherapy, radiation,or other anti-cancer medication no more than 3 weeks;
• \. Patients with severe disorders of heart, lung, liver, kidney function or irreversible coagulation disorder;
• \. 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;
• \. Pregnant or lactating women.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Fudan University: collaborator
• Ruijin Hospital: collaborator
• Changhai Hospital: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 16019852 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.

  PMID: 17110769 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.

  PMID: 18470620 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.

  PMID: 19219697 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.

  PMID: 24732979 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.

  PMID: 27162549 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Interventions

Cryosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Radiofrequency Therapy; Therapeutics

Study Officials

• Lisaxu Xu, MD. PhD.

  Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Xudong Qu, MD. PhD.

CONTACT

+86-021-64041990; qu.xudong@zs-hospital.sh.cn

Wentao Li, MD. PhD.

CONTACT

+86-021-64175590; liwentao98@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 21, 2017

Record last verified: 2016-09

Locations

CN (1)