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Completed

NCT Number: NCT03259581

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Bilirubinemia Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hyperbilirubinemia Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Procedure related adverse events

    Time frame: 1 month

    Percentage of adverse events following TACE

Secondary outcomes

  1. Radiologic Response

    Time frame: 1 month

    mRECIST response after TACE

  2. Progression free survival

    Time frame: 1, 3, 6, 12, 18, and 24 months

    Liver PFS and overall PFS

  3. Overall survival

    Time frame: 24 months

    Overall survival

  4. Change in Model for end stage liver disease (MELD)

    Time frame: 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

  5. Change in Child Pugh score

    Time frame: 7 and 30 days

    Change in Child Pugh score at 7 and 30 days post TACE

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 23, 2017
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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