NCT06694636

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

July 24, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

Hepatocellular CarcinomaSympathetic NervesIntravascular Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective Response Rate

    every month, up to 1 year

Secondary Outcomes (2)

  • PFS

    every month, up to 1 year

  • DCR

    every month, up to 1 year

Study Arms (1)

Intravascular Radiofrequency Ablation of Sympathetic Nerves Group

EXPERIMENTAL

Enrolled patients will receive Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma

Procedure: endovascular radiofrequency ablation and desympathetic nerve surgery

Interventions

endovascular radiofrequency ablation and desympathetic nerve surgery

Intravascular Radiofrequency Ablation of Sympathetic Nerves Group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Gao-Jun Gao-Jun

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teng

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Enrolled patients will receive intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Interventional and Vascular Surgery Department

Study Record Dates

First Submitted

July 24, 2024

First Posted

November 19, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations