Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT05842174
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    Hydroxychloroquine to be administered intra-arterially at time of transarterial embolization as well as orally for 6 weeks following the procedure
  • Lipiodol — DRUG
    Lipiodol is an FDA-approved drug delivered agent and embolic which is administered as standard of care for transarterial embolization for hepatocellular carcinoma. Lipiodol will be administered intra-arterially in both arms at the time of procedure.
  • Placebo — DRUG
    Placebo will be administered orally for 6 weeks following the procedure to patients in arm 2

Study Details

Trans-arterial chemoembolization (TACE) is the most commonly used therapy for patients with unresectable hepatocellular carcinoma (HCC). TACE is a minimally invasive procedure that involves placing a catheter into the artery in the liver that feeds the tumor, administering chemotherapeutics and then blocking the artery with embolics in order to kill tumor cells by depriving them of essential oxygen and nutrients. While TACE has a proven survival benefit, local recurrence is common, and long-term survival rates are poor. Prior studies demonstrate that HCC cells survive the oxygen and nutrient deprivation through autophagy, a process of cellular self-eating, to provide nutrients required for survival. The proposed project will leverage this dependency to develop a novel approach to TACE that integrates autophagy inhibition to improve therapeutic response by increasing tumor cell killing and enhancing anti-tumor immunity.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Oct 15, 2030

Study Design

Enrollment
93 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transarterial Embolization with Hydroxychloroquine
    Intra-arterial hydroxychloroquine in Lipiodol + transarterial embolization followed by oral hydroxychloroquine
  • Placebo Comparator: Transarterial Embolization without Hydroxychloquine
    Intra-arterial Lipiodol + transarterial embolization followed by oral placebo

Primary Outcome Measure

Local Progression Free Survival [ Time Frame: 6 months following treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
Terence P Gade, MD PhD
[email protected]
(215) 823-5800
David E. Kaplan, MD MSc (SUB_INVESTIGATOR)
Terence P Gade, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA· Philadelphia, PA

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