Liver CancerNCT04014478
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
A study testing Endovascular Denervation in people with Liver Cancer and Pancreas Cancer, run by Shanghai Golden Leaf MedTec Co. Ltd.
Trial summary
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers . Patients who have taken at least one opioid drug for pain for two weeks and still have a VAS pain scale greater than 6 will receive endovascular denervation (EDN). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Liver Cancer, Pancreas Cancer, Stomach Cancer
- What is being tested?
- Endovascular Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Jul 2021
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females with ages of 25 to 75;
- Clinically diagnosed as primary or secondary upper abdominal cancers (liver, pancreas, stomach, etc);
- Patients who have taken at least one opioid drug for pain for two weeks and still have VAS pain scale 》6;
- Expected lifetime 》4 months;
- Agrees to take part in the trial and signs the written, informed consent.
Who cannot join
- Women who are pregnant, or breast feeding, or having pregancy plan;
- Bleeding tendency or other coagulation related diseases;
- Acute or severe systemic infection;
- Past history of receving denervation procedure in aorta;
- No plans for surgical or interventional procedures in 3 months;
- History of stroke or TIA within 2 weeks;
- Acute coronary events within 2 weeks;
- Other conditions that deem unsuitable for the procedure, in the opinions of investigators.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers . Patients who have taken at least one opioid drug for pain for two weeks and still have a VAS pain scale greater than 6 will receive endovascular denervation (EDN). They will be followed up for 3 months. The VAS scales, quantity of analgesics as represented by morphine equivalent and quality of life scores will be compared before and after EDN. Safety parameters such as arterial deformation, embolism, infection, liver and kidney functions will also be monitored.
- Conditions
- Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer
- Being tested
- Endovascular Denervation
- Keywords
- Cancer； Pain
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Bile Duct Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular DenervationDevice
A radiofrequency ablation catheter will be placed in abdominal aorta. At least 6 sites will be ablated with settings of temerature at 60 degree centigrade and time at 120 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Denervation | Experimental | Not described Receives: Device: Endovascular Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Changes over the time
Pain scale is evaluated as Woodforde Visual Analig Scale (VAS) method. The scale is from 0 to 10, with 0 being no pain, and 10 being unbearable pain.
Measured: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Secondary outcomes (2)
Morphine Equivalent Changes over the time
All analgesics used will be calculated to Morphine Equivalent using published conversion factors.
Measured: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Quality of Life Score Changes over the time
Qulaity of Life Scores are obtained using Functional Assessment of Cancer Theray-Generic Scale (FACT-G) (v 4.0) sale. The score is from 0 to 108, with 0 being no quality of life, and 108 being highest quality of life.
Measured: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start15 Jul 2019 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gao-Jun Teng, MD, Study chair, Zhongda Hospitalzhong-Min Wang, MD, Principal investigator, Shanghai JiaoTong University Affiliated RuiJin HospitalJian Wang, MD, Principal investigator, Beijing University Affiliated the First HospitalWen-Tao Li, MD, Principal investigator, Fudan University Affiliated Cancer HospitalChuan-Sheng Zheng, MD, Principal investigator, HuaZhong University of Science and Technology Affiliated Union HospitalWei-Fu Lv, MD, Principal investigator, China University of Science and Technology Affiliated the First HospitalJun-Hui Sun, MD, Principal investigator, Zhejiang University Affiliated the First HospitalHao Xu, MD, Principal investigator, XuZhou Medical College Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014478
- Sponsor's protocol ID
- GL-CT-20161201
- Status last verified
- Jun 2019
- First submitted
- 1 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
- ClinicalTrials.gov ID
- NCT04014478
- Acronym / sponsor ID
- GL-CT-20161201
- Conditions
- Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer
- Keywords
- Cancer； Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 10 Jul 2019 (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.
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers . Patients who have taken at least one opioid drug for pain for two weeks and still have a VAS pain scale greater than 6 will receive endovascular denervation (EDN). They will be followed up for 3 months. The VAS scales, quantity of analgesics as represented by morphine equivalent and quality of life scores will be compared before and after EDN. Safety parameters such as arterial deformation, embolism, infection, liver and kidney functions will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Denervation | Experimental | Device: Endovascular Denervation |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females with ages of 25 to 75;
- Clinically diagnosed as primary or secondary upper abdominal cancers (liver, pancreas, stomach, etc);
- Patients who have taken at least one opioid drug for pain for two weeks and still have VAS pain scale 》6;
- Expected lifetime 》4 months;
- Agrees to take part in the trial and signs the written, informed consent.
Key exclusion criteria (8 listed)
- Women who are pregnant, or breast feeding, or having pregancy plan;
- Bleeding tendency or other coagulation related diseases;
- Acute or severe systemic infection;
- Past history of receving denervation procedure in aorta;
- No plans for surgical or interventional procedures in 3 months;
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 |
|---|---|---|
| Endovascular DenervationA radiofrequency ablation catheter will be placed in abdominal aorta. At least 6 sites will be ablated with settings of temerature at 60 degree centigrade and time at 120 seconds. | Device | Endovascular Denervation |
Primary outcome
Visual Analog Scale Changes over the time
Time frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Pain scale is evaluated as Woodforde Visual Analig Scale (VAS) method. The scale is from 0 to 10, with 0 being no pain, and 10 being unbearable pain.
2 secondary outcomes
Morphine Equivalent Changes over the time
Time frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Quality of Life Score Changes over the time
Time frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Yes
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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.
Gao-Jun Teng, MD study chair
Zhongda Hospital
zhong-Min Wang, MD principal investigator
Shanghai JiaoTong University Affiliated RuiJin Hospital
Jian Wang, MD principal investigator
Beijing University Affiliated the First Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Denervation in people with Liver Cancer and Pancreas Cancer, run by Shanghai Golden Leaf MedTec Co. Ltd.
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 5 inclusion and 8 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Hua Qing Yin, PhD (86-21-5486-8731, huaqing.yin@goldenleafmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Changes over the time (time frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2019.