Safety of Transarterial Chemoembolization (TACE) in the S... | NCT03259581

Studies
Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin

NCT03259581

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Mar 21, 2022Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Hepatocellular Carcinoma
Bilirubinemia

Interventions

Transarterial chemoembolization

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Feb 1, 2022Actual

First Submitted Date

Aug 1, 2017

First Submission Date that Met QC Criteria

Aug 21, 2017

First Posted Date

Aug 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2022

Last Update Posted Date

Mar 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transarterial chemoembolization	Experimental	Transarterial chemoembolization	Combination Product: Transarterial chemoembolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transarterial chemoembolization	Combination Product	Delivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedure related adverse events	Percentage of adverse events following TACE	1 month

Secondary Outcomes

Measure	Description	Time Frame
Radiologic Response	mRECIST response after TACE	1 month
Progression free survival	Liver PFS and overall PFS	1, 3, 6, 12, 18, and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hepatocellular carcinoma (HCC)
Direct or conjugated bilirubin < 3 mg/dl
Total bilirubin > 3 mg/dl
Willing and able to provide informed consent
>18 years of age

Exclusion Criteria:

Currently pregnant
Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
Arterial anatomy which would preclude selective transarterial chemoembolization
Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
Patients with extrahepatic metastases
Patients with portal vein invasion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D006932	Hyperbilirubinemia

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided