Purpose

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).

Category

IRB Number
20160515HU
NCT Number
NCT03037437
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Principal Investigator
Sukeshi Arora

Sukeshi Arora
(210) 450-1015
aroras@uthscsa.edu

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Jennifer Moseley
(210) 450-1799
moseleyj@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      Non-Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Hepatocellular Cancer

      2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Progress on sorafenib

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

      400mg by mouth daily

      Other names:

      • Plaquenil

    3. Drug: Sorafenib (SOR)

      Patients will receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1).

      Other names:

      • Nexavar

      4. Experimental

      No prior systemic treatment

      		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.
    4. Drug: Hydroxychloroquine (HCQ)

      400mg by mouth daily

      Other names:

      • Plaquenil

    5. Drug: Sorafenib (SOR)

      Patients will receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1).

      Other names:

      • Nexavar

      6.