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

Last updated: June 26, 2025
Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Overall Status: Terminated

Phase

N/A

Condition

Digestive System Neoplasms

Cancer/tumors

Liver Disorders

Treatment

microwave ablation

Clinical Study ID

NCT04520906
MWA1.0
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 maximumdiameter ≤ 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 thetrial and sign informed consent.

Exclusion

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 exceedsthe 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 forMRI examination.

  • Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 monthbefore 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 Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: microwave ablation
Phase:
Study Start date:
December 17, 2020
Estimated Completion Date:
April 01, 2023

Study 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.

Connect with a study center

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200120
    China

    Site Not Available

  • Ruijin Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • The Central Hospital of Lishui City

    Lishui, Zhejiang 323000
    China

    Site Not Available

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