Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

NCT02013778 | Terminated Phase 1 Results DMC

• 1 other identifier: UPCC 22213
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

outside of transplant criteria

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

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

  1 year

Study Arms (1)

TACE + HCQ

EXPERIMENTAL

Subjects will receive HCQ plus standard of care TACE.

Drug: HCQ

Interventions

HCQ DRUG

TACE + HCQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Gregory Nadolski, MD, Principal Investigator
• Organization: University of Pennsylvania

gregory.nadolski@pennmedicine.upenn.edu

215-662-7892

Study Officials

• Gregory Nadolski, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 17, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Locations

US (1)