NCT02969096

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

November 17, 2016

Last Update Submit

November 17, 2016

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Rate of complete tumor ablation

    Up to 4 weeks post surgery

Secondary Outcomes (1)

  • Adverse Events

    Up to 4 weeks post surgery

Study Arms (1)

Targeted Cryoablation Therapy

EXPERIMENTAL

liver cancer patients received targeted cryoablation therapy.

Procedure: Targeted Cryoablation Therapy

Interventions

Targeted Cryoablation TherapyPROCEDURE

A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.

Targeted Cryoablation Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of liver cancer based on histology or the current accepted radiological measures.
  • Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
  • Life expectancy: Greater than 3 months.
  • Patients' liver function is Child-pugh A or B.
  • Ability to understand the study protocol and a willingness to sign a written informed consent document.
  • Unable to receive operative surgery.

You may not qualify if:

  • Patients with other primary tumor except liver cancer.
  • History of coagulation disorders or anemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • qing wu, Bachelor

    Shanghai Longhua Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

CN(1)