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Spots Global Cancer Trial Database for Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer

Official Title: Modulation of Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer

Study ID: NCT03037437

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Texas Health Cancer Center, San Antonio, Texas, United States

Contact Details

Name: Sukeshi Patel Arora, MD

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

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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