Sorafenib + Hydroxychloroquine for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen bySukeshi Patel Arora, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The University of Texas Health Science Center at San Antonio

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC).

Research Team

Sukeshi Patel Arora, MD

Principal Investigator

Cancer Therapy & Research Center University of Texas Health Science Center San Antonio

Eligibility Criteria

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.

Inclusion Criteria

My liver function is moderately to mildly impaired.

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.

My liver cancer is confirmed and advanced or has spread.

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Exclusion Criteria

My psoriasis is under control and monitored by a specialist.

I have brain metastases but no symptoms and haven't taken corticosteroids for a week.

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

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Treatment Details

Interventions

Hydroxychloroquine (Autophagy Inhibitor)
Sorafenib (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Sorafenib is already approved in Canada, Japan for the following indications: