Nerve-Zapping procedure could boost liver cancer therapy
NCT ID NCT07187284
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether adding a nerve-zapping procedure called endovascular denervation (EDN) to standard liver cancer treatments (TACE/HAIC and immune-targeted drugs) can improve outcomes for people with advanced liver cancer that has spread to the portal vein and stopped responding to initial therapy. About 62 participants will be randomly assigned to receive either the combination or standard care alone. The goal is to see if the combo delays tumor growth and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endovascular denervation (EDN) plus transarterial chemoembolization/hepatic arterial infusion chemotherapy (TACE/HAIC) and immune-targeted therapy
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced liver cancer patients who have stopped responding to initial therapy, potentially improving tumor control and survival.
- What could go wrong
- This is an early Phase 1/2 trial with only 62 participants, so results are preliminary. The added nerve ablation procedure carries risks like bleeding or nerve damage, and the overall benefit over standard care is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 75 years (inclusive), regardless of gender. 2. Diagnosis of CNLC Stage IIIa HCC with portal vein tumor thrombus (vp type 1-3) confirmed by histopathology, cytology, or imaging. 3. Progression of disease after first-line systemic therapy. 4. At least one measurable lesion according to RECIST 1.1 criteria. 5. Child-Pugh class A or B. 6. ECOG performance status of 0 to 2. 7. Scheduled to undergo TACE or HAIC treatment. 8. Adequate hematological, hepatic, and renal function within 14 days prior to study initiation, defined as: White blood cell count ≥2.0×10⁹/L AND neutrophil count ≥1.0×10⁹/L. Platelet count ≥60×10⁹/L. Hemoglobin concentration ≥90 g/L. Total bilirubin ≤2.0 × upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN. Albumin ≥2.8 g/dL. International normalized ratio (INR) ≤1.6. Creatinine ≤1.5 × ULN AND calculated creatinine clearance ≥30 mL/min. Exclusion Criteria: 1. Preoperative abdominal CT or MR enhanced scan suggests celiac trunk anatomy is unsuitable for EDN procedure. 2. History of orthostatic hypotension. 3. Diffuse liver tumors or extensive extrahepatic metastases with an expected survival of \<3 months. 4. Cachexia or multi-organ failure. 5. Severe hepatic dysfunction (Child-Pugh class C). 6. Uncorrectable coagulation dysfunction. 7. Presence of severe concurrent infection. 8. Accompanied by Vp4 type portal vein tumor thrombus. 9. Abnormal blood supply to the target lesion that precludes transarterial interventional therapy. 10. History of bilioenteric anastomosis within the past year. 11. Severe allergy to known contrast agents or embolization materials. 12. Pregnant or lactating women, or individuals with childbearing potential planning pregnancy during the trial period. 13. Clinically significant (e.g., active) cardiovascular disease, including: Unstable angina within ≤6 months prior to randomization. New York Heart Association (NYHA) class ≥II congestive heart failure. Poorly controlled arrhythmia despite medication (patients with controlled atrial fibrillation are eligible), or any clinically significant abnormality found on resting ECG. ≥Grade 3 peripheral vascular disease (e.g., symptomatic and interfering with activities of daily living, requiring intervention). Transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization, or participation in other drug or device clinical trials within 3 months. 14. History of other malignancies within the past 5 years or concurrent other malignancies. 15. Any other condition deemed by the investigator as unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongda Hospital Affiliated to Southeast University, Department of Interventional and Vascular Surgery
Nanjing, Jiangsu, 210009, China
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