Recruiting at 1 site Phase 2 HCC - Hepatocellular Carcinoma

Clinical trial for HCC - Hepatocellular Carcinoma

Official title Defining the Ablative Dose for Y-90 TARE

ClinicalTrials.gov ID: NCT07586046

What this study is testing

What it's testing
The study aims to determine the optimal amount of radiation needed to completely destroy liver tumors that are not operable or treatable with standard ablation.
Who it's for
Adults with hepatocellular carcinoma (liver cancer) that cannot be removed by surgery or treated with standard ablation techniques.
What's involved
Participants will receive Y‑90 trans‑arterial radioembolization (TARE), a procedure that delivers radioactive microspheres to the liver tumor.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
  • Age ≥18 years.
  • Child-Pugh class A or B liver function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Leukocytes (WBC) ≥ 3,000/mcL

You likely can't join if

  • Extrahepatic metastases.
  • Pregnant or breastfeeding individuals.
  • Tumors requiring treatment of more than two Couinaud segments.
  • Known hypersensitivity to gadolinium-based contrast agents.
  • Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).
  • Coagulopathy or clinical instability precluding angiographic intervention.
See the full eligibility criteria
Who can join
  • Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
  • Age ≥18 years.
  • Child-Pugh class A or B liver function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Leukocytes (WBC) ≥ 3,000/mcL
  • Absolute neutrophil count (ANC) ≥ 1,500/mcL
  • Hemoglobin ≥ 9 g/dL
  • Platelets ≥ 50,000/mcL
  • Total bilirubin ≤ 3.0 mg/dL
  • AST ≤ 100 U/L, ALT ≤ 120 U/L
  • Creatinine ≤ 2.0 mg/dL or estimated GFR ≥ 40 mL/min/1.73 m²
  • Ability to undergo imaging and laboratory evaluations required by the study.
  • Ability to understand and willingness to sign a written informed consent document.
What rules you out
  • Extrahepatic metastases.
  • Pregnant or breastfeeding individuals.
  • Tumors requiring treatment of more than two Couinaud segments.
  • Known hypersensitivity to gadolinium-based contrast agents.
  • Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).
  • Coagulopathy or clinical instability precluding angiographic intervention.
  • Prisoners or individuals under legal custody.
  • Adults unable to consent.
  • Individuals under 18 years of age.

The study team makes the final eligibility decision.

Where it is enrolling

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.