Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: DEBDOX

• Registration Number: NCT02007954
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE) DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Study Start: 2014-02
• Status Verified: 2014-07
• Primary Completion: 2015-08-11
• Study Completion: 2016-11-18
• Results First Submitted: 2017-04-12
• Results First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Results First Posted: 2017-08-11
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEBDOX	DEBDOX	-

Primary Outcome Measures

Name	Time	Method
Success of DEBDOX-M1 Procedure as a Measure of Feasibility	6 months	Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.
Collection of Adverse Events Related to Study Device as a Measure of Safety	1 month	For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE.

Secondary Outcome Measures

Name	Time	Method
Efficacy - Tumor Response by EASL	1 month	Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments.; Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference.; Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1.; Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1.; Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1.
Efficacy - Tumor Response by qEASL	1 month	Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments.; Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.; Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions.; Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease.; Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions.
Efficacy - Tumor Response by mRECIST	1 month	Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments.; Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD.
Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions	6 months	The number of patients who underwent a liver transplantation following treatment on this protocol.
AFP Tumor Marker Pre- and Post-treatment	1 month	The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure.

Trial Locations

Locations (1)

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States