NCT02969096
Unknown
Phase 2
Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Shanghai University of Traditional Chinese Medicine1 site in 1 country30 target enrollmentStarted: October 2016Last updated:
ConditionsLiver Neoplasms
Overview
- Phase
- Phase 2
- Sponsor
- Shanghai University of Traditional Chinese Medicine
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of complete tumor ablation
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Rate of complete tumor ablation
Time Frame: Up to 4 weeks post surgery
Secondary Outcomes
- Adverse Events(Up to 4 weeks post surgery)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 1
Cryoablation Combined With Camrelizumab and Apatinib for Multiprimary Lung CancerLung CancerNCT04201990ShiYue Li20
Recruiting
Phase 1
Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung CancersLung CancerNCT06607770Zhou Chengzhi20
Unknown
Not Applicable
TURBt With Adjuvant Cryoablation to Treat Bladder CancerUrinary Bladder NeoplasmsNCT02760953Huashan Hospital150
Completed
Not Applicable
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of LumpectomyCarcinoma, Ductal, BreastMenopausalNCT02576106Centre Leon Berard22
Recruiting
Phase 2
Cryoablation Combined with Tislelizumab Plus Lenvatinib in Previously Treated Solid Tumors (CASTLE-11)Solid Tumor, AdultNCT06032845Fudan University25