A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of EUS-LA for Liver Cancer

Study Overview
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Brief Summary
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This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound-guided laser ablation by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.

Detailed Description
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The prospective, single-arm, multi-center clinical trial is to evaluate whether the endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System can achieve the safety and effectivenessof liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 69 subjects. Qualified participants will receive EUS-guided LA by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the complete ablation (CA) rate and the effective rate of EUS-guided LA by LaserPro Diode Laser System for liver cancer) and secondary outcomes (technical success rate, major complication rate, partial response rate, secondary ablation rate, progression-free survival (PFS), overall survival rate (OS), local tumor progression (LTP), distant tumor recurrence (DTR), quality of life score and alpha-fetoprotein levels). The one-month follow-up after the operation, three-phase MRI, liver function and tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, three-phase MRI of liver were examined every 2 to 3 months. After then, statistical comparisons of safety and effectivenessof the producedure will be made according to groups.

Official Title
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A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of Endoscopic Ultrasound-guided Laser Ablation for Liver Cancer by LaserPro Diode Laser System

Conditions
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Liver Cancer

Intervention / Treatment
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* Device: EUS-LA by LaserPro Diode Laser System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria. Liver tumors within the scope of EUS scanning. Single tumor≤ 3cm in diameter and the number of visible tumor were no more than 3. According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye. Liver function: Child-Pugh A or B. Age: 18-75 years old, regardless of gender. Patients signed informed consent to participate in the trial. Exclusion Criteria: Contraindication for EUS or the target tumor were beyond the scope of EUS scanning. Liver function: Child-pugh C, those could not improve after liver protective treatment. Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding; platelet count less than 50×109/L, prothrombin time more than 30s or prothrombin activity less than 40%. Severe failure of major organs such as kidney, heart, lung and brain. Uncontrolled infection in any organ, especially inflammation of the biliary system. Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment.

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: To evaluate whether the LaserPro Diode Laser System under the guidance of EUS can achieve the safety and effectiveness of local ablation for liver cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-LA by LaserPro Diode Laser System<br>This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups. | Device: EUS-LA by LaserPro Diode Laser System<br>* This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete ablation rate | Defined as the absence of any contrast uptake within or at the periphery of the ablative zone. One month after either one session or multiple LA sessions, CTA was confirmed by contrast-enhanced MRI. | 1 month | 
| Effectiveness analysis | The effective rate of EUS-LA by LaserPro Diode Laser System for liver cancer was evaluated by mRECIST criteria. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Technical success rate of EUS-LA by LaserPro Diode Laser System for liver cancer. | 1 month | 
| Major complication rate | Major complication rate after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Partial response rate | Partial response rate after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Secondary ablation rate | Secondary ablation rate after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Progression-free survival (PFS) | Progression-free survival after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Overall survival rate (OS) | Overall survival rate after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Local tumor progression (LTP) | Local tumor progression after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Distant tumor recurrence (DTR) | Distant tumor recurrence after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Quality of life score | Quality of life score of participants after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 
| Alpha-fetoprotein levels | The alpha-fetoprotein levels of participants after EUS-LA by LaserPro Diode Laser System for liver cancer. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cancer, laser, ablation, endoscopic ultrasound