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To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microwave ablation
Sponsored by
Suzhou Hengruihongyuan Medical Technology Co. LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma).
  • Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm.
  • No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis.
  • Child-Pugh class A or B classification, or meet the standard after treatment.
  • Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent.

Exclusion Criteria:

  • Pregnant or breastfeeding, or preparing to become pregnant during the trial.
  • Participating in clinical trials of other devices or drugs.
  • Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s).
  • PLT <50x109/L.
  • Intractable massive ascites.
  • Cachexia.
  • MRI examination is contraindicated or the investigator judges it is not suitable for MRI examination.
  • Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery.
  • Patients with impaired consciousness or unable to cooperate with treatment.
  • The investigator judged that it is not suitable to participate in clinical trials.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences
  • The First Affiliated Hospital of Fujian Medical University
  • Sun Yat-sen University Cancer Center
  • Henan Cancer Hospital
  • Zhongda Hospital Southeast UniversityRecruiting
  • The Second Affiliated Hospital of Soochow UniversityRecruiting
  • Shandong Provincial Hospital
  • Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine
  • Zhejiang Cancer Hospital
  • The Central Hospital of Lishui CityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm

Arm Description

Subjects will be treated with microwave ablation.

Outcomes

Primary Outcome Measures

Complete tumor ablation rate
the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.

Secondary Outcome Measures

First complete tumor ablation rate
the percentage of subjects who did not undergo the second one month after the operation accounted for all the ablation trials.
Complete ablation rate of lesions
the percentage of lesions that are completely ablated to all lesions undergoing ablation.

Full Information

First Posted
August 18, 2020
Last Updated
May 4, 2022
Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
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1. Study Identification

Unique Protocol Identification Number
NCT04520906
Brief Title
To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Official Title
Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.
Detailed Description
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, multi-center, single-group target value
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-arm
Arm Type
Experimental
Arm Description
Subjects will be treated with microwave ablation.
Intervention Type
Device
Intervention Name(s)
microwave ablation
Intervention Description
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
Primary Outcome Measure Information:
Title
Complete tumor ablation rate
Description
the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
First complete tumor ablation rate
Description
the percentage of subjects who did not undergo the second one month after the operation accounted for all the ablation trials.
Time Frame
1 month after surgery
Title
Complete ablation rate of lesions
Description
the percentage of lesions that are completely ablated to all lesions undergoing ablation.
Time Frame
1 month after 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: Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma). Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm. No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis. Child-Pugh class A or B classification, or meet the standard after treatment. Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent. Exclusion Criteria: Pregnant or breastfeeding, or preparing to become pregnant during the trial. Participating in clinical trials of other devices or drugs. Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s). PLT <50x109/L. Intractable massive ascites. Cachexia. MRI examination is contraindicated or the investigator judges it is not suitable for MRI examination. Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery. Patients with impaired consciousness or unable to cooperate with treatment. The investigator judged that it is not suitable to participate in clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaojun Teng, Doctor
Phone
+86-025-83272001
Email
gjteng@seu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaojun Teng, Doctor
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Li, Doctor
First Name & Middle Initial & Last Name & Degree
Xiao Li, Doctor
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengyu Lin, Doctor
First Name & Middle Initial & Last Name & Degree
Zhengyu Lin, Doctor
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijun Fan, Doctor
First Name & Middle Initial & Last Name & Degree
Weijun Fan, Doctor
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailiang Li, Doctor
First Name & Middle Initial & Last Name & Degree
Hailiang Li, Doctor
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaojun Teng, Doctor
Phone
+86-025-83272001
Email
gjteng@seu.edu.cn
First Name & Middle Initial & Last Name & Degree
Gaojun Teng, Doctor
First Name & Middle Initial & Last Name & Degree
Haidong Zhu, Doctor
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Jin, Doctor
First Name & Middle Initial & Last Name & Degree
Yong Jin, Doctor
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Ye, Doctor
First Name & Middle Initial & Last Name & Degree
Xin Ye, Doctor
Facility Name
Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongmin Wang, Doctor
First Name & Middle Initial & Last Name & Degree
Zhongmin Wang, Doctor
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Meng, Doctor
First Name & Middle Initial & Last Name & Degree
Zhiqiang Meng, Doctor
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenggang Ren, Doctor
First Name & Middle Initial & Last Name & Degree
Zhenggang Ren, Doctor
Facility Name
Renji Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Zhai, Doctor
First Name & Middle Initial & Last Name & Degree
Bo Zhai, Doctor
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Xu, Doctor
First Name & Middle Initial & Last Name & Degree
Dong Xu, Doctor
Facility Name
The Central Hospital of Lishui City
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiansong Ji, Doctor
First Name & Middle Initial & Last Name & Degree
Jiansong Ji, Doctor

12. IPD Sharing Statement

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To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer

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