A Pilot Study of 68Ga-PSMA-11 PET-directed Radioligand Therapy in Patients With Metastatic Hepatocellular Carcinoma (HCC)
Melissa Lumish
Summary
The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate specific membrane antigen (PSMA) positive liver cancer.
Description
Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide, with more than 900,000 newly diagnosed cases and approximately 830,000 deaths in 2020. Surgical resection and liver transplantation are potential curative options for patients with early-stage HCC. However, most patients present with metastatic and/or unresectable disease and systemic treatment is the only therapeutic option for these patients. Although several ICI-based combination therapies have recently extended survival for many patients with HCC, biomarker-directed strategies are limited for thi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically, cytologically or radiographically confirmed hepatocellular carcinoma by LI-RADS30 with metastatic and/or unresectable disease. * Participants must have received one prior line of systemic therapy for the treatment of metastatic and/or unresectable HCC including anti-PD-L1 therapy. Participants will be enrolled at the time of progression on first-line therapy for metastatic and/or unresectable disease. * Age \>18 years. Because no dosing or adverse event data are currently available on the use of 177Lu-PSMA-617 (Lu-177 vipivotide tet…
Interventions
- DrugLu-PSMA-617
Given IV
Location
- Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center, Seidman Cancer CenterCleveland, Ohio