Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

NCT ID: NCT02013778

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-02-28

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE + HCQ

Subjects will receive HCQ plus standard of care TACE.

Group Type: EXPERIMENTAL

HCQ

Intervention Type: DRUG

Interventions

HCQ

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Nadolski, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UPCC 22213

Identifier Type: -

Identifier Source: org_study_id