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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520906
• Other study ID #: MWA1.0
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: Suzhou Hengruihongyuan Medical Technology Co. LTD
• Contact: Gaojun Teng, Doctor
• Phone: +86-025-83272001
• Email: gjteng[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

Device:
• microwave ablation
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	The Central Hospital of Lishui City	Lishui	Zhejiang
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Ruijin Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Hengruihongyuan Medical Technology Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Complete ablation rate of lesions	the percentage of lesions that are completely ablated to all lesions undergoing ablation.	1 month after surgery