Liver CancerNCT05709886
A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of EUS-LA for Liver Cancer
A study testing EUS-LA by LaserPro Diode Laser System in people with Liver Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- EUS-LA by LaserPro Diode Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Tian'an Jiang, PhD, 86-18857127666, tiananjiang@126.com
About this study
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
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- EUS-LA by LaserPro Diode Laser System
- Keywords
- liver cancer, laser, ablation, endoscopic ultrasound
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-LA by LaserPro Diode Laser SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EUS-LA by LaserPro Diode Laser System | Experimental | 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. Receives: Device: EUS-LA by LaserPro Diode Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Effectiveness analysis
The effective rate of EUS-LA by LaserPro Diode Laser System for liver cancer was evaluated by mRECIST criteria.
Measured: 6 months
Secondary outcomes (10)
Technical success rate
Technical success rate of EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 1 month
Major complication rate
Major complication rate after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Partial response rate
Partial response rate after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Secondary ablation rate
Secondary ablation rate after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Progression-free survival (PFS)
Progression-free survival after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Overall survival rate (OS)
Overall survival rate after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Local tumor progression (LTP)
Local tumor progression after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Distant tumor recurrence (DTR)
Distant tumor recurrence after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Quality of life score
Quality of life score of participants after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Alpha-fetoprotein levels
The alpha-fetoprotein levels of participants after EUS-LA by LaserPro Diode Laser System for liver cancer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start28 Feb 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yiwu Central Hospital, Zhejiang Provincial Tongde Hospital
- Responsible party
- Sponsor
- Investigators
- Tian'an Jiang, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709886
- Sponsor's protocol ID
- eusLAliver
- Status last verified
- Dec 2022
- First submitted
- 25 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29031662Hong 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.
PubMed 16757969Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.
PubMed 30970190Petrowsky 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.
PubMed 32681074Pacella 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.
PubMed 19332729Arienti 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.
PubMed 18195382Di 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.
PubMed 25251043Di 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.
PubMed 25349642Pacella 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.
PubMed 22191028Chai 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.
PubMed 31383020Di 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.
PubMed 21030019Jiang 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.
PubMed 27958384Jiang 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.
PubMed 29303406
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05709886
- Acronym / sponsor ID
- eusLAliver
- Conditions
- Liver Cancer
- Keywords
- liver cancer, laser, ablation, endoscopic ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yiwu Central Hospital, Zhejiang Provincial Tongde Hospital
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| EUS-LA by LaserPro Diode Laser System | Experimental | Device: EUS-LA by LaserPro Diode Laser SystemThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-LA by LaserPro Diode Laser SystemThis 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 |
Primary outcome
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.
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.
10 secondary outcomes
Technical success rate
Time frame: 1 month
Major complication rate
Time frame: 6 months
Partial response rate
Time frame: 6 months
Secondary ablation rate
Time frame: 6 months
Progression-free survival (PFS)
Time frame: 6 months
Overall survival rate (OS)
Time frame: 6 months
Local tumor progression (LTP)
Time frame: 6 months
Distant tumor recurrence (DTR)
Time frame: 6 months
Quality of life score
Time frame: 6 months
Alpha-fetoprotein levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 29031662Nault 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.
- Background: PubMed 16757969Hong 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.
- Background: PubMed 30970190Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.
- Background: PubMed 32681074Petrowsky 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.
- Background: PubMed 19332729Pacella 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.
- Background: PubMed 18195382Arienti 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.
- Background: PubMed 25251043Di 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.
- Background: PubMed 25349642Di 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.
- Background: PubMed 22191028Pacella 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.
- Background: PubMed 31383020Chai 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.
- Background: PubMed 21030019Di 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.
- Background: PubMed 27958384Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tian'an Jiang, PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-LA by LaserPro Diode Laser System in people with Liver Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian'an Jiang, PhD (86-18857127666, tiananjiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709886, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.