Autophagy Inhibition + TACE for Liver Cancer
(TAQE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byTerence P Gade, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: VA Office of Research and Development

Trial Summary

What is the purpose of this trial?

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.

Research Team

Terence P Gade, MD PhD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Eligibility Criteria

This trial is for adults diagnosed with a specific stage of liver cancer (BCLC B HCC) who are about to undergo TACE therapy. They must have a tumor at least 3 cm wide, be in relatively good health (Childs Pugh Turcotte A/B7, Performance Status 0), and agree to follow the study rules. People can't join if they're pregnant or breastfeeding, have had previous treatments on the target lesion, suffer from certain eye conditions or heart issues, or have other serious medical problems.

Inclusion Criteria

My liver cancer is at least 3 cm wide and meets specific imaging criteria.

I am 18 or older with a diagnosis of intermediate-stage liver cancer and referred for a specific liver cancer treatment.

Informed of investigational nature of this study with provision of signed and dated informed consent form

See 2 more

Exclusion Criteria

I am not pregnant or breastfeeding.

QT prolongation on ECG

Contraindication to contrast enhanced MRI or metallic implant within the liver

See 6 more

Treatment Details

Interventions

Hydroxychloroquine (Autophagy Inhibitor)
Lipiodol (Chemotherapy)
Placebo (Other)
TACE (Chemotherapy)

Trial OverviewThe study tests whether adding Hydroxychloroquine—an autophagy inhibitor—to standard TACE treatment improves outcomes by killing more cancer cells and boosting anti-tumor immunity compared to TACE alone. Some patients will receive Lipiodol with Hydroxychloroquine while others get Lipiodol with a placebo.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transarterial Embolization with HydroxychloroquineExperimental Treatment2 Interventions

Intra-arterial hydroxychloroquine in Lipiodol + transarterial embolization followed by oral hydroxychloroquine

Group II: Transarterial Embolization without HydroxychloquinePlacebo Group2 Interventions

Intra-arterial Lipiodol + transarterial embolization followed by oral placebo