Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

Study Overview
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Brief Summary
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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.

Official Title
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Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: HCQ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient capable of giving informed consent Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL. Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania. Age 18 years old Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5 Creatinine 2.0 mg/dL, AST 121 IU/L; ALT 189 IU/L Child-Turcotte-Pugh Classification A or B Eastern Clinical Oncology Group performance status 0 or1. Exclusion Criteria: Prior TACE Active GI hemorrhage within 2 weeks of study enrollment Ascites refractory to medical therapy Contraindication to receiving HCQ or TACE Unilobar HCC Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging) Women who are pregnant Participation in another concurrent treatment protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE + HCQ<br>Subjects will receive HCQ plus standard of care TACE. | Drug: HCQ<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outside of transplant criteria