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

May 4, 2022 updated by: Suzhou Hengruihongyuan Medical Technology Co. LTD

Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Xiao Li, Doctor
        • Principal Investigator:
          • Xiao Li, Doctor
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Not yet recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Zhengyu Lin, Doctor
        • Principal Investigator:
          • Zhengyu Lin, Doctor
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Weijun Fan, Doctor
        • Principal Investigator:
          • Weijun Fan, Doctor
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Hailiang Li, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
        • Principal Investigator:
          • Gaojun Teng, Doctor
        • Sub-Investigator:
          • Haidong Zhu, Doctor
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
          • Yong Jin, Doctor
        • Principal Investigator:
          • Yong Jin, Doctor
    • Shandong
      • Jinan, Shandong, China, 250021
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Xin Ye, Doctor
        • Principal Investigator:
          • Xin Ye, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Zhiqiang Meng, Doctor
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Zhongmin Wang, Doctor
        • Principal Investigator:
          • Zhongmin Wang, Doctor
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Zhongshan Hospital
        • Contact:
          • Zhenggang Ren, Doctor
      • Shanghai, Shanghai, China, 200120
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Bo Zhai, Doctor
        • Principal Investigator:
          • Bo Zhai, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Dong Xu, Doctor
        • Principal Investigator:
          • Dong Xu, Doctor
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • The Central Hospital of Lishui City
        • Contact:
          • Jiansong Ji, Doctor
        • Principal Investigator:
          • Jiansong Ji, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-arm
Subjects will be treated with microwave ablation.
Device: microwave ablation
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete tumor ablation rate
Time Frame: 1 month after surgery

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.
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First complete tumor ablation rate
Time Frame: 1 month after surgery
the percentage of subjects who did not undergo the second one month after the operation accounted for all the ablation trials.
1 month after surgery
Complete ablation rate of lesions
Time Frame: 1 month after surgery
the percentage of lesions that are completely ablated to all lesions undergoing ablation.
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

Investigators

  • Principal Investigator: Gaojun Teng, Doctor, Zhongda Hospital Southeast University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWA1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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