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

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: Terminated
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: microwave ablation

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 (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital Of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200120
      • Renji Hospital, Shanghai Jiao Tong University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Lishui, Zhejiang, China, 323000
      • The Central Hospital of Lishui City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	the percentage of lesions that are completely ablated to all lesions undergoing ablation.	1 month after surgery

Collaborators and Investigators

• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
• Investigators: Principal Investigator: Gaojun Teng, Doctor, Zhongda hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 1, 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 (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: MWA1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No