Spots Global Cancer Trial Database for Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC
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Trial Identification
Brief Title: Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC
Official Title: Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma
Study ID: NCT02013778
Conditions
Interventions
Study Description
Brief Summary: Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
Name: Gregory Nadolski, MD
Affiliation: Abramson Cancer Center at Penn Medicine
Role: PRINCIPAL_INVESTIGATOR
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