Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma

November 18, 2024 updated by: Gao-jun Teng, Zhongda Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Teng

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravascular Radiofrequency Ablation of Sympathetic Nerves Group
Enrolled patients will receive Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
Procedure: endovascular radiofrequency ablation and desympathetic nerve surgery
endovascular radiofrequency ablation and desympathetic nerve surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: every month, up to 1 year
Objective Response Rate
every month, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: every month, up to 1 year
Progression Free Survival
every month, up to 1 year
DCR
Time Frame: every month, up to 1 year
disease control rate
every month, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Gao-Jun Gao-Jun, Zhongda hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024ZDSYLL167-P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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