Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma

Liver Neoplasms Clinical Trial

Official title:

Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02969096
• Other study ID #: AAAA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 17, 2016
• Last updated: November 17, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Procedure:
• Targeted Cryoablation Therapy
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.

Locations

Country	Name	City	State
China	Shanghai Longhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete tumor ablation		Up to 4 weeks post surgery	No
Secondary	Adverse Events		Up to 4 weeks post surgery	No