Can two radiation therapies team up to fight liver cancer?
NCT ID NCT04518748
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial is testing whether combining two types of radiation therapy can safely treat liver cancer that cannot be removed with surgery. The approach uses Y-90 microspheres delivered directly to the liver, followed by targeted external radiation (SBRT). The study also uses PET-CT imaging to help plan the radiation more precisely. The main goal is to check the safety of this combination and see how it affects liver function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Yttrium-90 (Y-90) microspheres given via selective internal radiation therapy (SIRT), followed by stereotactic body radiation therapy (SBRT)
- What this could lead to
- If safe and effective, this combination could offer a new way to treat liver cancer that cannot be removed surgically, potentially improving local control of tumors.
- What could go wrong
- This is an early-phase trial focused on safety, so the combination may not prove more effective than standard treatments. There is a risk of liver damage or other side effects from the radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
70 people
The number who actually took part.
- Started
-
Sep 2020
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following: * Biopsy proven hepatocellular carcinoma (HCC); or * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria. Metastatic liver cancer is defined as having: o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease * Patients must not have known untreated or progressive disease outside of the liver * At least one lesion \>2 cm diameter or 4 cc volume * Patients must have a life expectancy of at least 6 months. * Patients must be 18 years of age or older * All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment. * Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks. Exclusion Criteria: * Inability to lie still for imaging studies (e.g. PET/CT) * Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction. * Patients with known allergy or contraindication to intravenous iodinated contrast agents * Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium) * Contraindication to Theraspheres * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques * Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs. * Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis; * Bilirubin \>2.0 at baseline * Occlusion of the main portal vein * Contraindication to radiation therapy * Note: Patients who have an increase in bilirubin \>1.0 from the time of Y90 to SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatocellular carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial