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Autophagy Inhibitor

Autophagy Inhibition + TACE for Liver Cancer (TAQE Trial)

Phase 1 & 2
Waitlist Available
Led By Terence P Gade, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following treatment

Summary

This trial uses trans-arterial chemoembolization (TACE) to kill tumor cells by blocking artery supplying them with oxygen and nutrients. It also introduces an approach to TACE that uses autophagy inhibition to increase tumor cell killing and create anti-tumor immunity.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Hydroxychloroquine may cause side effects like vision changes due to retinopathy risk, digestive disturbances such as nausea and diarrhea, skin rashes especially in those with psoriasis history, and muscle weakness. It's important for participants to report any new symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local Progression Free Survival

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5350
Lipiodol
2019
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,632 Total Patients Enrolled
Terence P Gade, MD PhDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Media Library

Hydroxychloroquine (Autophagy Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05842174 — Phase 1 & 2
Liver Cancer Research Study Groups: Transarterial Embolization with Hydroxychloroquine, Transarterial Embolization without Hydroxychloquine
Liver Cancer Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT05842174 — Phase 1 & 2
Hydroxychloroquine (Autophagy Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05842174 — Phase 1 & 2
~62 spots leftby Aug 2027
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