NCT05842174 Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma
| NCT ID | NCT05842174 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 93 participants in total. It began in 2026-04-01 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Male or female, aged 18 years, meeting criteria for diagnosis of BCLC B HCC and referred to undergo TACE * HCC measuring 3 cm in minimum transverse diameter and meets LI-RADS 5 criteria based on cross-sectional imaging as determined by a board-certified, sub-specialty trained radiologist * Childs Pugh Turcotte A/B7, Performance Status 0 * Informed of investigational nature of this study with provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * QT prolongation on ECG * Retinopathy on ophthalmologic examination * Females who are pregnant or breast feeding at the time of screening will not be eligible for this study * a serum or urine pregnancy test will be performed in women of child-bearing potential at screening * Prior LRT or systemic therapy to the target lesion * Contraindication to contrast enhanced MRI or metallic implant within the liver. * HCQ allergy, porphyria, uncontrolled psoriasis, and existing retinopathy * Lesion not amenable to biopsy based on pre-TACE imaging as determined by treating interventional radiologist * Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study)
Contact & Investigator
Terence P Gade, MD PhD
PRINCIPAL INVESTIGATOR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Frequently Asked Questions
Who can join the NCT05842174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05842174 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05842174 currently recruiting?
Yes, NCT05842174 is actively recruiting participants. Contact the research team at Terence.Gade@va.gov for enrollment information.
Where is the NCT05842174 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05842174 clinical trial?
NCT05842174 is sponsored by VA Office of Research and Development. The principal investigator is Terence P Gade, MD PhD at Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA. The trial plans to enroll 93 participants.
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