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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
Awards & highlights
TAQE Trial 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.Check my eligibility
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.See study design
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.
TAQE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months following treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local Progression Free Survival
TAQE 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
~5360
Lipiodol
2019
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,510 Total Patients Enrolled
Terence P Gade, MD PhDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer is at least 3 cm wide and meets specific imaging criteria.I am not pregnant or breastfeeding.I have had previous treatments on the cancer spot.I am 18 or older with a diagnosis of intermediate-stage liver cancer and referred for a specific liver cancer treatment.My lesion cannot be biopsied according to my latest imaging results.My liver functions well enough for treatment, and I can care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: Transarterial Embolization with Hydroxychloroquine
- Group 2: Transarterial Embolization without Hydroxychloquine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals participate in this research at the moment?
"Unfortunately, the clinical trial in question is no longer recruiting patients. Initially posted on September 1st 2023 and most recently edited on April 21st 2023, it has been supplanted by 3032 other active trials that are collectively seeking study participants."
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