NCT03037437

Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer

Modulation of Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Phase 2 study with two cohorts: Cohort 1: As second-line treatment, we will add HCQ to SOR dose the patient was tolerating at the time of progression. Cohort 2: SOR-naïve patients receive SOR 400 mg by PO twice daily on Cycle1 Day1 (C1D1). On Cycle 1 Day 15, HCQ 400 mg PO daily will be started. In clinical practice, dose reduction of SOR may be required. On C1D15 SOR maybe kept as starting dose or reduced for toxicity. On Cycle 2 Day 1 of toxicity of HCQ and SOR will be assessed. Each cycle is 28 days. Blood samples will be collected at Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 to assess for biomarkers. Disease evaluation every 2 cycles. Dose reductions due to adverse events are allowed for both sorafenib per standard of care and/or HCQ for grade 3 or more adverse event was related to study medication. Dose reductions are also permitted based on investigator clinical decision.

Conditions

• Hepatocellular Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib (SOR)	Patients will receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1).
DRUG	Hydroxychloroquine (HCQ)	400mg by mouth daily

Timeline

• Start date: 2017-02-16
• Primary completion: 2025-06-27
• Completion: 2025-06-27
• First posted: 2017-01-31
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study