Back to resultsClinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Primary Purpose
Liver Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Targeted Cryoablation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Liver Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of liver cancer based on histology or the current accepted radiological measures.
- Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
- Life expectancy: Greater than 3 months.
- Patients' liver function is Child-pugh A or B.
- Ability to understand the study protocol and a willingness to sign a written informed consent document.
- Unable to receive operative surgery.
Exclusion Criteria:
- Patients with other primary tumor except liver cancer.
- History of coagulation disorders or anemia.
Sites / Locations
- Shanghai Longhua Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targeted Cryoablation Therapy
Arm Description
liver cancer patients received targeted cryoablation therapy.
Outcomes
Primary Outcome Measures
Rate of complete tumor ablation
Secondary Outcome Measures
Adverse Events
Full Information
NCT ID
NCT02969096
First Posted
November 17, 2016
Last Updated
November 17, 2016
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02969096
Brief Title
Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Official Title
Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.
Detailed Description
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Targeted Cryoablation Therapy
Arm Type
Experimental
Arm Description
liver cancer patients received targeted cryoablation therapy.
Intervention Type
Procedure
Intervention Name(s)
Targeted Cryoablation Therapy
Intervention Description
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.
Primary Outcome Measure Information:
Title
Rate of complete tumor ablation
Time Frame
Up to 4 weeks post surgery
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
Up to 4 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of liver cancer based on histology or the current accepted radiological measures.
Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
Life expectancy: Greater than 3 months.
Patients' liver function is Child-pugh A or B.
Ability to understand the study protocol and a willingness to sign a written informed consent document.
Unable to receive operative surgery.
Exclusion Criteria:
Patients with other primary tumor except liver cancer.
History of coagulation disorders or anemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
qing wu, Bachelor
Organizational Affiliation
Shanghai Longhua Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
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