Phase 2 Study of 68Ga-PSMA-11 PET-Guided Radioligand Therapy with 177Lu-PSMA-617 in Adults with Metastatic Hepatocellular Carcinoma

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.

68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)