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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: microwave ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, multi-center, single-group target value
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |