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

Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03259581

Enrollment

Registered

2017-08-23

Start date

2018-01-02

Completion date

2022-02-01

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilirubinemia, Hepatocellular Carcinoma

Keywords

transarterial chemoembolization

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.

Interventions

COMBINATION_PRODUCTTransarterial chemoembolization

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Radiologic Response	1 month	mRECIST response after TACE
Progression free survival	1, 3, 6, 12, 18, and 24 months	Liver PFS and overall PFS
Overall survival	24 months	Overall survival
Change in Model for end stage liver disease (MELD)	7 and 30 days	Change in MELD (MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43) score at 7 and 30 days post TACE
Change in Child Pugh score	7 and 30 days	Change in Child Pugh score at 7 and 30 days post TACE

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026