Hepatocellular CarcinomaNCT06694636
Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
A study testing endovascular radiofrequency ablation and desympathetic nerve surgery in people with Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
Patients who met the inclusion criteria were treated with endovascular radiofrequency ablation and desympathetic nerve surgery. After enrollment, endovascular radiofrequency ablation and desympathetic surgery were performed. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- endovascular radiofrequency ablation and desympathetic nerve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinically or pathologically confirmed hepatocellular carcinoma (HCC)
- Locally progressed or distant metastatic unresectable advanced HCC
- Progressed after second-line therapy
- Agree to participate in the study and sign the informed consent form
Who cannot join
- Not suitable for ablation surgery
- Pregnant, lactating and planning to become pregnant
- Orthostatic hypotension
- Mixed liver cancer
- Intestinal obstruction
- Obvious bleeding tendencies and hematologic diseases
Show all 10Show fewer
- Acute or severe systemic infection;
- Stroke or transient ischemic attack (TIA) within two weeks;
- Acute coronary syndrome within two weeks;
- Evaluated to be not suitable for this trial by investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Teng contact
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Teng Gaojun, 86-02583272121, gjteng@vip.sina.com
About this study
Patients who met the inclusion criteria were treated with endovascular radiofrequency ablation and desympathetic nerve surgery. After enrollment, endovascular radiofrequency ablation and desympathetic surgery were performed. After radiofrequency ablation, the safety and efficacy of follow-up treatment will be carried out every 1 month or so, including blood routine, liver and kidney function, tumor indicators, abdominal CT/magnetic resonance, etc.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- endovascular radiofrequency ablation and desympathetic nerve surgery
- Keywords
- Hepatocellular Carcinoma, Sympathetic Nerves, Intravascular Radiofrequency Ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular radiofrequency ablation and desympathetic nerve surgeryProcedure or surgery
endovascular radiofrequency ablation and desympathetic nerve surgery
| Study group | Role | What they receive |
|---|---|---|
| Intravascular Radiofrequency Ablation of Sympathetic Nerves Group | Experimental | Enrolled patients will receive Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma Receives: Procedure: endovascular radiofrequency ablation and desympathetic nerve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: every month, up to 1 year
Secondary outcomes (2)
PFS
Progression Free Survival
Measured: every month, up to 1 year
DCR
disease control rate
Measured: every month, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Model description
- Enrolled patients will receive intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Gao-Jun, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694636
- Sponsor's protocol ID
- 2024ZDSYLL167-P01
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06694636
- Acronym / sponsor ID
- 2024ZDSYLL167-P01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Sympathetic Nerves, Intravascular Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 19 Nov 2024 (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.
Patients who met the inclusion criteria were treated with endovascular radiofrequency ablation and desympathetic nerve surgery. After enrollment, endovascular radiofrequency ablation and desympathetic surgery were performed. After radiofrequency ablation, the safety and efficacy of follow-up treatment will be carried out every 1 month or so, including blood routine, liver and kidney function, tumor indicators, abdominal CT/magnetic resonance, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled patients will receive intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
| Arm | Type | Receives |
|---|---|---|
| Intravascular Radiofrequency Ablation of Sympathetic Nerves Group | Experimental | Procedure: endovascular radiofrequency ablation and desympathetic nerve surgeryEnrolled patients will receive Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically or pathologically confirmed hepatocellular carcinoma (HCC)
- Locally progressed or distant metastatic unresectable advanced HCC
- Progressed after second-line therapy
- Agree to participate in the study and sign the informed consent form
Key exclusion criteria (10 listed)
- Not suitable for ablation surgery
- Pregnant, lactating and planning to become pregnant
- Orthostatic hypotension
- Mixed liver cancer
- Intestinal obstruction
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 radiofrequency ablation and desympathetic nerve surgeryendovascular radiofrequency ablation and desympathetic nerve surgery | Procedure or surgery | Intravascular Radiofrequency Ablation of Sympathetic Nerves Group |
Primary outcome
ORR
Time frame: every month, up to 1 year
Objective Response Rate
2 secondary outcomes
PFS
Time frame: every month, up to 1 year
DCR
Time frame: every month, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Teng contact
Gao-Jun Gao-Jun principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular radiofrequency ablation and desympathetic nerve surgery in people with Hepatocellular Carcinoma, run by Zhongda Hospital 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai-Dong Zhu (+86-25-83272121, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: every month, up to 1 year). 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 19 Nov 2024.