Status and phase
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About
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.
Full description
LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accepted for treatment of HCC. This novel bead slowly releases the ionically bound chemotherapeutic agent rather than administering a bolus of chemotherapy as is the case with many alternative methods of TACE. Thus, the LC BeadTM offers the potential advantage of less toxicity and prolonged tumor exposure.
This study offers local regional therapy to a defined population of patients beyond transplant criteria as an attempt to downstage them to eligibility for liver transplantation. This study will make an important contribution to understanding the beads' local effect as seen in the explanted livers of those patients who go on to receive a liver transplant. Additionally, we will examine the impact of this novel treatment tool on patients' quality of life.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Adults patients (≥ 18 years of age) with a diagnosis of HCC that is not amenable to surgical resection or local ablative therapy
Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2cm with typical vascular features or AFP > 200
Patient must have one lesion < 8cm or up to five lesions with total diameter < 8cm
Quantifiable disease limited to the liver; 40% of liver must be free of tumor burden
Patient must have at least one tumor lesion that meets both of the following criteria:
ECOG performance status ≤ 2
No prior systemic chemotherapy
At least 4 weeks since prior TACE or interferon
Not pregnant
No significant baseline liver dysfunction. Child-Pugh class A and B 7-8 (in abscence of ascites)
No significant renal impairment (creatinine clearance < 30mL/minute) or patients on dialysis
No current infections requiring antibiotic therapy
Not on anticoagulation or suffering from a known bleeding disorder
No unstable coronary artery disease or recent MI
The following laboratory parameters
Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
HCC with gross vascular invasion or extrahepatic disease
Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), and any cancer curatively treated > 3 years prior to entry is permitted
Renal failure requiring dialysis
Child-Pugh B9 or C hepatic impairment
History of cardiac disease: NYHA class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
Active clinically serious infections (> CTCAEv3 grade 2)
Known history of HIV
Known central nervous system tumors including metastatic brain disease
History of organ allograft
Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
Allergy to the investigational agents or any agent given in association with this trial.
Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Serious non-healing wound, ulcer, or bone fracture
Any contraindication for doxorubicin administration:
Any contraindication for hepatic embolization procedures
Excluded therapies and medications, previous and concomitant:
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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