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

February 13, 2023 updated by: First Affiliated Hospital of Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
  2. Liver tumors within the scope of EUS scanning.
  3. 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.
  4. Liver function: Child-Pugh A or B.
  5. Age: 18-75 years old, regardless of gender.
  6. Patients signed informed consent to participate in the trial.

Exclusion Criteria:

  1. Contraindication for EUS or the target tumor were beyond the scope of EUS scanning.
  2. Liver function: Child-pugh C, those could not improve after liver protective treatment.
  3. 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%.
  4. Severe failure of major organs such as kidney, heart, lung and brain.
  5. Uncontrolled infection in any organ, especially inflammation of the biliary system.
  6. Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EUS-LA by LaserPro Diode Laser System
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

Yiwu Central Hospital
Zhejiang Provincial Tongde Hospital

Investigators

  • Principal Investigator: Tian'an Jiang, PhD, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 28, 2023

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

March 31, 2025

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eusLAliver

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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