Actively Recruiting
A Pilot Study of 68Ga-PSMA-11 PET-directed Radioligand Therapy in Patients With Metastatic Hepatocellular Carcinoma (HCC)
Led by Melissa Lumish · Updated on 2026-05-08
10
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
M
Melissa Lumish
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a drug called 177Lu-PSMA-617 in patients who have metastatic hepatocellular carcinoma (HCC), a type of liver cancer that is often advanced and cannot be surgically removed. This study focuses on patients whose tumors show positive uptake of prostate specific membrane antigen (PSMA), a protein found in tumor blood vessels and targeted for treatment. The trial aims to explore the potential of PSMA-targeted therapy in HCC, a disease with limited biomarker-directed options despite recent improvements from immunotherapy. Participants will receive intravenous infusions of 177Lu-PSMA-617 at a dose of 7.4 GBq (200 mCi) every six weeks. The treatment uses a radioligand approach, where the drug delivers targeted radiation to PSMA-positive tumor cells identified through special PET imaging. The study includes one main treatment arm and will monitor treatment effects and safety over time, with dosing repeated at six-week intervals. During the study, participants will undergo PSMA PET scans to confirm tumor uptake, and researchers will track side effects and treatment responses through imaging and laboratory tests. Outcomes measured include the percentage of participants with PSMA-positive lesions, safety and tolerability of the drug, progression-free survival, overall survival, and tumor response rates. The study will follow participants for several months to assess these outcomes and monitor long-term safety.
CONDITIONS
Brief Title
68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed hepatocellular carcinoma that is metastatic or cannot be surgically removed.
- Participants must have received one prior systemic therapy including anti-PD-L1 treatment for their liver cancer.
- Participants must be 18 years or older.
- Participants must have a performance status of 0 or 1 on the ECOG scale.
- Participants must have normal organ and marrow function as defined by specific blood counts and kidney function.
- Participants must have Child-Pugh class A or B7 liver function.
- Participants must have at least one measurable tumor lesion.
- Participants must show PSMA-positive lesions on PET imaging.
- Participants must be able to understand and consent to the study.
- Participants of childbearing potential must use effective contraception.
You will not qualify if you...
- Participants receiving other investigational treatments.
- Participants who received investigational therapy within 4 weeks or 5 half-lives before the study.
- Participants with ongoing severe toxicity from previous cancer treatments.
- Participants previously treated with Y90 radioembolization for liver cancer.
- Participants who had major surgery within 3 months and have not recovered.
- Participants with active additional cancers requiring treatment, except some skin or cervical cancers.
- Participants with untreated brain metastases or carcinomatous meningitis.
- Participants with uncontrolled illnesses such as infection, heart failure, unstable angina, arrhythmia, or psychiatric issues.
- Participants with psychiatric or substance use disorders interfering with study compliance.
- Pregnant or breastfeeding participants, or those planning pregnancy during and shortly after the trial.
- Participants who received live vaccines within 30 days prior to the first treatment.
- Participants with recent or high risk of bleeding events such as variceal or gastrointestinal bleeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 6-week cycles until disease progression or discontinuation
Participants receive intravenous 177Lu-PSMA-617 once every 6 weeks as radioligand therapy for metastatic hepatocellular carcinoma.
1 visit every 6 weeks
Duration - Up to 240 days post treatment
Participants are monitored for safety and treatment outcomes after completing radioligand therapy.
Visits as scheduled for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
M
Melissa Lumish, MD
A
Amit Mahipal, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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