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Kinase Inhibitor

Sorafenib + Hydroxychloroquine for Liver Cancer

Phase 2

Waitlist Available

Led By Sukeshi Patel Arora, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child-Pugh class A or B7 liver function

Cytologically or histologically confirmed advanced or metastatic HCC. If no histological diagnosis, patient must have imaging studies compatible with HCC.

Must not have

Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. Patients with NG-tube, J-tube, or G-tube will not be allowed to participate.

Patients requiring the use of enzyme-inducing anti-epileptic medication (phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine) are not eligible for entry into the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing if the cancer drug sorafenib, when combined with the drug hydroxychloroquine, is more effective than sorafenib alone in treating advanced liver cancer.

Who is the study for?

This trial is for adults with advanced liver cancer who have either not had systemic treatments or those whose disease progressed after at least 4 weeks on sorafenib. They must be in good physical condition, not candidates for curative treatment, and have a life expectancy over 3 months. Exclusions include allergies to similar drugs as HCQ, certain uncontrolled illnesses, brain metastases, and pregnancy.

What is being tested?

The study tests if combining Hydroxychloroquine (HCQ) with Sorafenib improves outcomes in advanced liver cancer compared to Sorafenib alone. It's specifically for patients new to treatment or those whose cancer grew despite prior Sorafenib use.

What are the potential side effects?

Potential side effects may include digestive issues like nausea and diarrhea from HCQ; skin reactions; eye problems such as retinopathy; and heart complications including arrhythmias. Sorafenib can cause hand-foot skin reactions, high blood pressure, fatigue, and increased risk of bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function is moderately to mildly impaired.

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My liver cancer is confirmed and advanced or has spread.

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I agree to use two forms of birth control if I'm a woman not in menopause or surgically sterile, or a barrier method if I'm a man.

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My recent blood tests meet the study's health requirements.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I cannot undergo surgery or transplantation to cure my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take pills by mouth due to stomach or intestine problems.

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I am not taking any seizure medications that affect enzyme levels.

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I have signed the consent form and understand the study procedures.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant and agree to use birth control during the study.

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I have previously been treated with hydroxychloroquine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to tumor progression evaluated via tumor imaging

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Progress on sorafenibExperimental Treatment2 Interventions

As second-line treatment, we will add hydroxychloroquine (HCQ) to sorafenib (SOR) dose the patient was tolerating at the time of progression.

Group II: No prior systemic treatmentExperimental Treatment2 Interventions

Sorafenib (SOR)-naïve patients receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1). In clinical practice, dose reduction of SOR is often required. Therefore, on C1D15, the clinician will dose-reduce sorafenib based on toxicity and hydroxychloroquine (HCQ) 400 mg PO daily will be started. C2D1 of each cohort, toxicity of HCQ will be assessed. Dose reductions due to adverse events (AEs) to each agent are allowed for SOR per standard of care and/or HCQ for grade 3+ AE.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydroxychloroquine

FDA approved

0 / 13Eligibility criteria met