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

July 17, 2017 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-modal Precision Ablation
In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation
Device: Multi-modal Precision Ablation
In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation
Other Names:
  • cryoablation
  • radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate
Time Frame: From date of randomization until the date of progression of ablation lesion, assessed up to 5 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of randomization until the date of death, assessed up to 5 years.
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.
Progression free survival (PFS)
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.
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.
Complication rate
Time Frame: 6 months
Number of participants with adverse events and complication
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

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

Investigators

  • Study Chair: Lisaxu Xu, MD. PhD., Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604159-3-1605&1604159-3-1606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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