Yttrium-90 Radiation for Liver Cancer

MA
Overseen ByMaya Aslam
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Yttrium-90 Radiation Segmentectomy for individuals with liver cancer that cannot be treated surgically. It focuses on those with either a single tumor between 2-5 cm or 2-3 small tumors, each 3 cm or less. Participants will receive a dose of tiny radioactive beads and will be monitored for safety and effects on quality of life. This trial may suit individuals with confirmed liver cancer who have not received previous treatment for their tumors and are not eligible for surgery. As an unphased trial, it offers patients the chance to explore a novel treatment option that could potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other anti-cancer agents while participating.

What prior data suggests that Yttrium-90 Radiation Segmentectomy is safe for liver cancer patients?

In a previous study, patients with liver cancer who received Yttrium-90 radiation segmentectomy had an average tumor dose of 232 Gy. This treatment uses tiny glass beads to deliver radiation directly to tumors. Research has shown that 88% of patients responded positively to the treatment for at least a year.

Another study found that 93% of patients who later underwent a liver transplant or surgery lived for at least three years after receiving TheraSphere, a type of Yttrium-90 therapy. These results suggest that the treatment is generally well-tolerated.

Safety data indicates that side effects are usually manageable. Patients receive close monitoring to quickly address any side effects. Overall, the treatment has been used in other studies and is considered safe for many liver cancer patients.12345

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for liver cancer, which often include surgery, chemotherapy, or external beam radiation, Yttrium-90 Radiation Segmentectomy uses tiny radioactive beads, known as TheraSphere® microspheres, that are delivered directly to the tumor. This treatment is unique because it targets the tumor from within, delivering high doses of radiation directly to cancer cells while sparing the surrounding healthy tissue. Researchers are excited about this method because it allows for precise treatment of even small or multiple tumors, potentially leading to better outcomes and fewer side effects compared to traditional treatments.

What evidence suggests that Yttrium-90 Radiation Segmentectomy might be an effective treatment for liver cancer?

Studies have shown that Yttrium-90 radiation segmentectomy holds promise for treating liver cancer, particularly hepatocellular carcinoma (HCC). Research indicates that 85% of patients experience tumor shrinkage or halted growth. Additionally, 95% achieve disease control, preventing further cancer growth. One study found that 88% of patients had a positive response in individual tumors, with 72% maintaining this response for a year or more. The treatment also demonstrates a high overall survival rate, with 93% of patients living three years after receiving TheraSphere. In this trial, participants will receive TheraSphere® Yttrium-90 microspheres, with one group having a single tumor and another group having 2-3 tumors. These findings suggest that Yttrium-90 radiation effectively manages liver cancer.12356

Who Is on the Research Team?

RL

Ryan Lokken, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with unresectable liver cancer (HCC) at an early stage, who haven't had prior treatments targeting the tumor. They must have a specific level of liver function and overall health, not be candidates for surgery or thermal ablation, and meet certain tumor size criteria. People with severe allergies to contrast agents, other active cancers, significant heart or lung conditions, uncontrolled bleeding disorders, or those pregnant/breastfeeding cannot join.

Inclusion Criteria

My liver cancer diagnosis was confirmed by a biopsy or imaging.
Ability to understand and sign informed consent document
I am HIV-positive, on treatment, and my viral load has been undetectable for the last 6 months.
See 9 more

Exclusion Criteria

Severe allergy to iodinated contrast agents
Pregnant or breastfeeding women
My liver cancer has grown into blood vessels.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of TheraSphere® Yttrium-90 microspheres for radiation segmentectomy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, quality of life, and survival outcomes

Up to 3 years
Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Yttrium-90 Radiation Segmentectomy
Trial Overview The study tests Yttrium-90 glass microspheres (TheraSphere®) delivered through arteries directly to the liver tumors in patients with HCC. It's a Phase II trial assessing how well this treatment works on its own without previous therapies interfering. Participants will also complete quality of life questionnaires.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2. TheraSphere® Yttrium-90 microspheresExperimental Treatment2 Interventions
Group II: Group 1. TheraSphere® Yttrium-90 microspheresExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Efficacy and Safety of Radiation Segmentectomy with 90 Y ...Among patients with HCC who underwent RS with 90Y resin microspheres, 88% and 72% achieved a per-lesion and overall duration of response of 1 ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38713023/
Efficacy and Safety of Radiation Segmentectomy with 90Y ...Among patients with HCC who underwent RS with 90 Y resin microspheres, 88% and 72% achieved a per-lesion and overall duration of response of 1 year or greater, ...
TheraSphere Y-90: Precision Liver Cancer Care93% OS. Overall Survival rate in patients with transplant or resection following TheraSphere at 3 years in the LEGACY study. · 26.6 months · 20.3 months.
Yttrium-90 Radiation Segmentectomy for Hepatocellular ...This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass ...
Yttrium-90 Radiation Segmentectomy of Hepatocellular ...The objective response and disease control rates were 85% and 95% for the overall cohort, respectively. The overall mean TD delivered was 680 Gy ± 512, while ...
Radiation segmentectomy for early hepatocellular ...CPN has been shown to be associated with favourable outcomes in patients treated using the RADSEG method. A recent multicentre study of 45 explanted patients ...
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