Study on Targeting Ischemia-Induced Autophagy in Liver Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05842174

Provider View

This clinical trial is exploring a new approach to treat liver cancer by combining a standard procedure called TACE with a drug that blocks a survival process in cancer cells, aiming to improve treatment outcomes.

Patient Parameters

Program Overview

Trans-arterial chemoembolization (TACE) is a common treatment for liver cancer that cannot be removed by surgery. It involves inserting a tube into the liver's artery to deliver cancer-fighting drugs and block the artery, cutting off the tumor's oxygen and nutrients. While TACE can help patients live longer, the cancer often comes back, and long-term survival is low. Research shows that liver cancer cells can survive by using a process called autophagy, where they recycle parts of themselves to get nutrients. This study aims to improve TACE by adding a drug that stops autophagy, hoping to kill more cancer cells and boost the body's immune response against the tumor.

Description

Currently, surgery or liver transplant are the only ways to cure liver cancer, but most patients are not eligible for these options. TACE is the standard treatment for those who cannot have surgery. It involves blocking the liver's blood supply to the tumor and delivering chemotherapy directly to it. Although TACE can extend life, the cancer often returns, and only a small percentage of tumors are completely destroyed. This is because cancer cells adapt to the lack of oxygen and nutrients by using autophagy, a survival mechanism.

This study will test a new method of TACE that includes a drug called hydroxychloroquine (HCQ) to block autophagy. The goal is to see if this combination can kill more cancer cells and improve the immune system's ability to fight the cancer. The trial will involve giving HCQ directly into the liver during TACE and then taking it orally for six weeks. Researchers will monitor the effects through follow-up biopsies and blood tests.

The trial has three main goals: (1) to ensure the safety of combining HCQ with TACE in patients with intermediate-stage liver cancer; (2) to compare the effectiveness of TACE with and without HCQ; and (3) to study how the treatment affects the immune system locally and throughout the body.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older with a specific type of liver cancer (BCLC B HCC) who are scheduled for TACE.
  • Tumor must be at least 3 cm in size and meet specific imaging criteria.
  • Must have good liver function and overall health.
  • Must understand the study and agree to participate by signing a consent form.
  • Must be willing to follow all study procedures and be available for the entire study duration.

Exclusion Criteria

  • Heart rhythm issues shown on an ECG.
  • Eye problems found during an eye exam.
  • Women who are pregnant or breastfeeding cannot participate.
  • Previous treatments to the target tumor.
  • Cannot have an MRI with contrast or have metal implants in the liver.
  • Allergies to HCQ or certain medical conditions like porphyria or uncontrolled psoriasis.
  • Tumors that cannot be biopsied based on imaging.
  • Serious medical or psychological conditions that could affect safety or participation.

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