Back to resultsA Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
Primary Purpose
Liver Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nanosecond knife liver cancer ablation
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring nanosecond knife, liver cancer
Eligibility Criteria
Inclusion Criteria:
- Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
- Age: 18-75 years old, regardless of gender.
- Liver function: Child-Pugh A or B, or Child C will reach B.
- No serious heart, lung, brain and other organ dysfunction. Normal or nearly normal blood coagulation function. Prothrombin time does not exceed 50% of the normal control, and platelets are more than 50 × 109 / L.
- It is usually suitable for single tumor with a maximum diameter of ≤5cm, or the number of tumors of ≤3 and a maximum diameter of ≤3cm.
- For single tumors > 5 cm in diameter that cannot be surgically removed, or multiple tumors with a maximum diameter > 3 cm, local ablation can be used as p palliative comprehensive treatment.
- According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
- Patients signed informed consent to participate in the trial.
Exclusion Criteria:
- The lesion of liver cancer is huge or diffuse ;
- Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
- tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
- liver function: Child-pugh C, those could not improve after liver protective treatment;
- Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
- Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding;
- Refractory large amount of ascites and cachexia;
- active infection, especially inflammation of the biliary system;
- Severe failure of major organs such as liver, kidney, heart, lung and brain;
- Patients with unconsciousness or unable to cooperate with treatment;
- Subjects could not be followed up and fell off;
- Those who discontinued treatment, or the case records were incomplete for various reasons, and were determined by researchers to be unable to be evaluated.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nanosecond knife group
Arm Description
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Outcomes
Primary Outcome Measures
Effectiveness analysis
The effective rate of nanosecond knife ablation for liver cancer
Secondary Outcome Measures
Secondary validity analysis
partial response rate of nanosecond knife ablation for liver cancer
Secondary validity analysis
secondary ablation rate of nanosecond knife ablation for liver cancer
Secondary validity analysis
progression-free survival of nanosecond knife ablation for liver cancer
Secondary validity analysis
overall survival rate of nanosecond knife ablation for liver cancer
Secondary validity analysis
quality of life score of nanosecond knife ablation for liver cancer
Secondary validity analysis
alpha-fetoprotein levels
Secondary validity analysis
technical success rate of nanosecond knife ablation for liver cancer
Secondary validity analysis
local control rate of nanosecond knife ablation for liver cancer
Secondary validity analysis
complication rate of nanosecond knife ablation for liver cancer
Secondary validity analysis
device Use satisfaction of nanosecond knife ablation for liver cancer
Full Information
NCT ID
NCT04309747
First Posted
March 10, 2020
Last Updated
March 15, 2020
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Shulan (Hangzhou) Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04309747
Brief Title
A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
Official Title
A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Shulan (Hangzhou) Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Detailed Description
The prospective, multi-center, single-arm clinical trial is to evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 190 subjects. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the effective rate of nanosecond knife ablation for liver cancer) and secondary outcomes (partial response rate, secondary ablation rate, progression-free survival, overall survival rate, quality of life score, alpha-fetoprotein levels, technical success rate, local control rate, complication rate, device Use satisfaction of nanosecond knife ablation for liver cancer). The first 2-month follow-up after the operation, CT, MR, CEUS, liver function, tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 2 to 3 months. After two years, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 3 to 6 months. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
nanosecond knife, liver cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nanosecond knife group
Arm Type
Experimental
Arm Description
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Intervention Type
Procedure
Intervention Name(s)
nanosecond knife liver cancer ablation
Intervention Description
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Primary Outcome Measure Information:
Title
Effectiveness analysis
Description
The effective rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary validity analysis
Description
partial response rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
secondary ablation rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
progression-free survival of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
overall survival rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
quality of life score of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
alpha-fetoprotein levels
Time Frame
12 months
Title
Secondary validity analysis
Description
technical success rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
local control rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
complication rate of nanosecond knife ablation for liver cancer
Time Frame
12 months
Title
Secondary validity analysis
Description
device Use satisfaction of nanosecond knife ablation for liver cancer
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
Age: 18-75 years old, regardless of gender.
Liver function: Child-Pugh A or B, or Child C will reach B.
No serious heart, lung, brain and other organ dysfunction. Normal or nearly normal blood coagulation function. Prothrombin time does not exceed 50% of the normal control, and platelets are more than 50 × 109 / L.
It is usually suitable for single tumor with a maximum diameter of ≤5cm, or the number of tumors of ≤3 and a maximum diameter of ≤3cm.
For single tumors > 5 cm in diameter that cannot be surgically removed, or multiple tumors with a maximum diameter > 3 cm, local ablation can be used as p palliative comprehensive treatment.
According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
Patients signed informed consent to participate in the trial.
Exclusion Criteria:
The lesion of liver cancer is huge or diffuse ;
Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
liver function: Child-pugh C, those could not improve after liver protective treatment;
Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding;
Refractory large amount of ascites and cachexia;
active infection, especially inflammation of the biliary system;
Severe failure of major organs such as liver, kidney, heart, lung and brain;
Patients with unconsciousness or unable to cooperate with treatment;
Subjects could not be followed up and fell off;
Those who discontinued treatment, or the case records were incomplete for various reasons, and were determined by researchers to be unable to be evaluated.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tian'an Jiang, PhD
Phone
18857127666
Email
tiananjiang@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Citations:
PubMed Identifier
18477802
Citation
Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
Results Reference
background
PubMed Identifier
21128329
Citation
Gu YK, Luo RG, Huang JH, Si Tu QJ, Li XX, Gao F. Transarterial embolization ablation of hepatocellular carcinoma with a lipiodol-ethanol mixture. World J Gastroenterol. 2010 Dec 7;16(45):5766-72. doi: 10.3748/wjg.v16.i45.5766.
Results Reference
background
PubMed Identifier
20308465
Citation
Bargellini I, Vignali C, Cioni R, Petruzzi P, Cicorelli A, Campani D, De Simone P, Filipponi F, Bartolozzi C. Hepatocellular carcinoma: CT for tumor response after transarterial chemoembolization in patients exceeding Milan criteria--selection parameter for liver transplantation. Radiology. 2010 Apr;255(1):289-300. doi: 10.1148/radiol.09090927.
Results Reference
background
PubMed Identifier
28109674
Citation
Fruhling P, Nilsson A, Duraj F, Haglund U, Noren A. Single-center nonrandomized clinical trial to assess the safety and efficacy of irreversible electroporation (IRE) ablation of liver tumors in humans: Short to mid-term results. Eur J Surg Oncol. 2017 Apr;43(4):751-757. doi: 10.1016/j.ejso.2016.12.004. Epub 2017 Jan 11.
Results Reference
background
PubMed Identifier
28799842
Citation
Distelmaier M, Barabasch A, Heil P, Kraemer NA, Isfort P, Keil S, Kuhl CK, Bruners P. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017 Dec;285(3):1023-1031. doi: 10.1148/radiol.2017161561. Epub 2017 Aug 11.
Results Reference
background
PubMed Identifier
11592607
Citation
Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.
Results Reference
background
PubMed Identifier
35912221
Citation
Xu M, Xu D, Dong G, Ren Z, Zhang W, Aji T, Zhao Q, Chen X, Jiang T. The Safety and Efficacy of Nanosecond Pulsed Electric Field in Patients With Hepatocellular Carcinoma: A Prospective Phase 1 Clinical Study Protocol. Front Oncol. 2022 Jul 13;12:869316. doi: 10.3389/fonc.2022.869316. eCollection 2022.
Results Reference
derived
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A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
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