Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer
Phase 2 study with two cohorts (Figure 1):
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). In clinical practice, dose reduction of SOR is often required.12 Therefore, on C1D15, the clinician will dose-reduce sorafenib based on toxicity and 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 (Table 2).
Blood samples will be collected at C1D1, C1D15 and C2D1 to assess for biomarkers.
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.