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Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HCQ

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring outside of transplant criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TACE + HCQ

Arm Description

Subjects will receive HCQ plus standard of care TACE.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0

Secondary Outcome Measures

Full Information

NCT ID

NCT02013778

First Posted

December 12, 2013

Last Updated

April 7, 2020

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02013778

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 Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

November 2013 (Actual)

Primary Completion Date

November 2018 (Actual)

Study Completion Date

February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

outside of transplant criteria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TACE + HCQ

Arm Type

Experimental

Arm Description

Subjects will receive HCQ plus standard of care TACE.

Intervention Type

Drug

Intervention Name(s)

HCQ

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory Nadolski, MD

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

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