Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02013778
• Other study ID #: UPCC 22213
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 2013
• Est. completion date: February 2019

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• HCQ

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0	1 year