What is 177Lu-PSMA-617 studying for metastatic hepatocellular carcinoma?

This trial is studying the effects of the drug 177Lu-PSMA-617 in patients with advanced liver cancer that shows PSMA protein on tumor vessels. Researchers want to evaluate how this targeted radioligand therapy works and whether it is safe for patients whose cancer has spread or cannot be removed by surgery.

Who may be eligible for this liver cancer clinical trial?

Adults 18 years or older with confirmed metastatic or unresectable hepatocellular carcinoma who have received prior systemic therapy including anti-PD-L1 treatment may be eligible. Both men and women can participate if they meet health and organ function requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this liver cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06852820

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

Participants Needed

Research Sites

17 weeks

Total Duration

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

Age: 18Years +

All Genders

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.

Research Team

Melissa Lumish, MD

Amit Mahipal, MBBS

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