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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05709886
• Other study ID #: eusLAliver
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Tian'an Jiang, PhD
• Phone: 86-18857127666
• Email: tiananjiang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Yiwu Central Hospital, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

Arienti V, Pretolani S, Pacella CM, Magnolfi F, Caspani B, Francica G, Megna AS, Regine R, Sponza M, Antico E, Di Lascio FM. Complications of laser ablation for hepatocellular carcinoma: a multicenter study. Radiology. 2008 Mar;246(3):947-55. doi: 10.1148/radiol.2463070390. Epub 2008 Jan 14. — View Citation

Chai W, Zhao Q, Song H, Cheng C, Tian G, Jiang T. Treatment response and preliminary efficacy of hepatic tumour laser ablation under the guidance of percutaneous and endoscopic ultrasonography. World J Surg Oncol. 2019 Aug 5;17(1):133. doi: 10.1186/s12957-019-1677-6. — View Citation

Di Costanzo GG, Francica G, Pacella CM. Laser ablation for small hepatocellular carcinoma: State of the art and future perspectives. World J Hepatol. 2014 Oct 27;6(10):704-15. doi: 10.4254/wjh.v6.i10.704. — View Citation

Di Costanzo GG, Tortora R, D'Adamo G, De Luca M, Lampasi F, Addario L, Galeota Lanza A, Picciotto FP, Tartaglione MT, Cordone G, Imparato M, Mattera S, Pacella CM. Radiofrequency ablation versus laser ablation for the treatment of small hepatocellular carcinoma in cirrhosis: a randomized trial. J Gastroenterol Hepatol. 2015 Mar;30(3):559-65. doi: 10.1111/jgh.12791. — View Citation

Di Matteo F, Grasso R, Pacella CM, Martino M, Pandolfi M, Rea R, Luppi G, Silvestri S, Zardi E, Costamagna G. EUS-guided Nd:YAG laser ablation of a hepatocellular carcinoma in the caudate lobe. Gastrointest Endosc. 2011 Mar;73(3):632-6. doi: 10.1016/j.gie.2010.08.019. Epub 2010 Oct 27. No abstract available. — View Citation

Hong K, Georgiades CS, Geschwind JF. Technology insight: Image-guided therapies for hepatocellular carcinoma--intra-arterial and ablative techniques. Nat Clin Pract Oncol. 2006 Jun;3(6):315-24. doi: 10.1038/ncponc0512. — View Citation

Jiang T, Tian G, Bao H, Chen F, Deng Z, Li J, Chai W. EUS dating with laser ablation against the caudate lobe or left liver tumors: a win-win proposition? Cancer Biol Ther. 2018 Mar 4;19(3):145-152. doi: 10.1080/15384047.2017.1414760. Epub 2018 Jan 25. — View Citation

Jiang TA, Deng Z, Tian G, Zhao QY, Wang WL. Efficacy and safety of endoscopic ultrasonography-guided interventional treatment for refractory malignant left-sided liver tumors: a case series of 26 patients. Sci Rep. 2016 Dec 13;6:36098. doi: 10.1038/srep36098. — View Citation

Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13. — View Citation

Pacella CM, Francica G, Di Costanzo GG. Laser ablation for small hepatocellular carcinoma. Radiol Res Pract. 2011;2011:595627. doi: 10.1155/2011/595627. Epub 2011 Dec 4. — View Citation

Pacella CM, Francica G, Di Lascio FM, Arienti V, Antico E, Caspani B, Magnolfi F, Megna AS, Pretolani S, Regine R, Sponza M, Stasi R. Long-term outcome of cirrhotic patients with early hepatocellular carcinoma treated with ultrasound-guided percutaneous laser ablation: a retrospective analysis. J Clin Oncol. 2009 Jun 1;27(16):2615-21. doi: 10.1200/JCO.2008.19.0082. Epub 2009 Mar 30. — View Citation

Petrowsky H, Fritsch R, Guckenberger M, De Oliveira ML, Dutkowski P, Clavien PA. Modern therapeutic approaches for the treatment of malignant liver tumours. Nat Rev Gastroenterol Hepatol. 2020 Dec;17(12):755-772. doi: 10.1038/s41575-020-0314-8. Epub 2020 Jul 17. — View Citation

Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Effectiveness analysis	The effective rate of EUS-LA by LaserPro Diode Laser System for liver cancer was evaluated by mRECIST criteria.	6 months
Secondary	Technical success rate	Technical success rate of EUS-LA by LaserPro Diode Laser System for liver cancer.	1 month
Secondary	Major complication rate	Major complication rate after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Partial response rate	Partial response rate after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Secondary ablation rate	Secondary ablation rate after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Progression-free survival (PFS)	Progression-free survival after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Overall survival rate (OS)	Overall survival rate after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Local tumor progression (LTP)	Local tumor progression after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Distant tumor recurrence (DTR)	Distant tumor recurrence after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Quality of life score	Quality of life score of participants after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months
Secondary	Alpha-fetoprotein levels	The alpha-fetoprotein levels of participants after EUS-LA by LaserPro Diode Laser System for liver cancer.	6 months