Study on 68Ga-PSMA-11 PET-directed Radioligand Therapy for Advanced Liver Cancer

Sponsor: Melissa Lumish

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06852820

Provider View

This clinical trial is exploring the effects of a new drug, 177Lu-PSMA-617, on patients with liver cancer that shows a specific protein called PSMA. The study aims to understand both the benefits and side effects of this treatment.

Patient Parameters

Program Overview

The purpose of this study is to investigate how a new treatment, 177Lu-PSMA-617, affects patients with advanced liver cancer that has spread or cannot be removed by surgery. This treatment targets a protein called PSMA, which is found in certain cancer cells. Researchers want to see if this approach can help control the cancer and improve patient outcomes.

Description

Liver cancer, specifically hepatocellular carcinoma (HCC), is a major cause of cancer-related deaths worldwide. Many patients are diagnosed when the cancer has already spread or cannot be surgically removed, leaving systemic treatment as the only option. This study focuses on a new treatment that targets a protein called PSMA, which is found in prostate cancer and other solid tumors, including liver cancer.

The study uses a special imaging technique called PSMA PET to identify patients whose liver cancer cells have high levels of PSMA. These patients will receive a drug called 177Lu-PSMA-617, which is designed to target and treat these cancer cells. Previous studies have shown that this approach can be effective in prostate cancer, and researchers are now exploring its potential in liver cancer.

The study will involve patients who have already received one type of systemic therapy for their liver cancer but need further treatment. Participants will undergo various tests and procedures to monitor the effects of the treatment and ensure their safety. The goal is to determine if this new approach can help control liver cancer and improve survival rates.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed liver cancer that has spread or cannot be removed by surgery.
  • Must have received one prior systemic therapy for liver cancer, including anti-PD-L1 therapy.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still carry out light work.
  • Must have normal organ and blood function based on specific medical tests.
  • Must have at least one measurable tumor.
  • Must show PSMA positivity in the tumor through PSMA PET imaging.
  • Must be able to understand and sign a consent form.
  • Women of childbearing age must use effective contraception.

Exclusion Criteria

  • Currently receiving other investigational treatments.
  • Have received investigational therapy recently.
  • Have severe side effects from previous cancer treatments.
  • Have had certain types of radiation treatment for liver cancer.
  • Have had major surgery recently and not fully recovered.
  • Have another active cancer requiring treatment, except for certain skin cancers or cervical cancer that has been treated.
  • Have untreated brain cancer or related conditions.
  • Have uncontrolled health issues like infections, heart problems, or psychiatric conditions that could interfere with the study.
  • Are pregnant or breastfeeding, or planning to conceive during the study period.
  • Have received a live vaccine recently.
  • Have a high risk of bleeding or recent bleeding issues.

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