Status:
WITHDRAWN
Study in the Treatment of HCC With a Radiopaque (RO) Bead (LC Bead LUMI™) Loaded With Doxorubicin
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Biocompatabilities UK Ltd
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. This type of cancer may be "hypervascular". Hypervascular means there is an increased number or concentration of blood v...
Detailed Description
The usual treatment for HCC is to perform a procedure to the tumor known as Transarterial Chemo-Embolization (TACE). TACE has been approved and used worldwide for over 10 years. Transarterial means t...
Eligibility Criteria
Inclusion
- Patient with HCC, diagnosed by at least one of the following:
- Imaging according to the American Association for the Study of Liver Disease (AASLD) guidelines
- Histology
- Adults (18 years of age or older)
- Tumor not suitable for resection, ablation or transplantation at the time of study entry
- Patient is a candidate for TACE after multidisciplinary team (MDT) decision
- HCC Barcelona Clinic Liver Cancer (BCLC) B or BCLC A not eligible for or refuses curative treatment, or BCLC C (Performance Status 1 only)
- At least one measurable disease according to mRECIST
- Preserved liver function (Child Pugh Score A and B7)
- Performance Status: Eastern Cooperative Oncology Group score of 0 or 1 or Karnofsky Performance Status 80 -100 at study entry
- TACE of all lesions can be achieved within a single cycle (2 sessions in 21 days +/- 7 days for the first cycle only)
- Life expectancy of at least 6 months at study entry
- Women and men of child bearing potential must agree to use adequate contraception prior, during and post therapy according to the standard instructions at the study site
- Negative serum or urine pregnancy test at study entry for woman of childbearing potential according to institutional policy
- Patient is willing and able to provide written signed and dated informed consent
Exclusion
- Extrahepatic metastases
- Portal vein tumor thrombosis (any type I to IV, refer to appendix 12.6)
- Patient on waiting list for transplantation
- Hematology:
- Hemoglobin \<9g/dL, or
- White Blood Cell (WBC) \<2,500 cells/mm3, or
- Absolute Neutrophil Count (ANC) \<1,500 cells/mm3, or
- Platelets \<50,000/mm3, or
- International Normalized Ratio (INR) \> 1.8
- Renal
- Glomerular Filtration Rate (GFR) \<30 mL/min/1.73m2
- Creatinine \>2 mg/dL
- Hepatic
- Any single tumor nodule \> 7cm (Multiple lesions can be included but not one \>7cm)
- Estimated tumor burden \>50%
- Clinically detectable ascites on physical exam (ascites detected by imaging only and is deemed not clinically significant is acceptable)
- Bleeding diathesis; history of hemorrhage / bleeding events
- Variceal bleeding of grade 3 or worse within 3 months of study entry
- Bilirubin \>3mg/dL,
- Significant impairment of liver function tests defined as AST/ALT \>5X Upper Limit Normal or 250 units/L
- Albumin \<30g/L
- Cardiovascular
- a. Significant cardiovascular disease; e.g., myocardial infarction within 6 months of inclusion, chronic heart failure (New York Heart Association class III or IV), Left Ventricular Ejection Fraction \<50%, unstable coronary artery disease
- Other serious concurrent medical conditions
- Previous malignancy other than carcinoma in situ of the skin, the cervix or uterus within 5 years prior to inclusion
- HIV, congenital immune defect, any immunosuppressive therapy for autoimmune disease (rheumatoid arthritis) or inflammatory bowel disease
- History of organ transplant
- Serious or chronic infection (Active, clinically severe bacteria or fungal infection of \>grade 2 NCI-CTCAE\_ v4.0)
- In case of Hepatitis B or C, viral disease must be under control (antiviral treatment not needed or completed or if hepatitis B with no interaction with cancer treatment).
- Other uncontrolled intercurrent underlying medical condition that in judgement of the investigator could impact the ability of the subject to participate in the trial
- Prior or concurrent cancer therapy
- Target lesions previously treated by a loco regional therapy (TACE, Y90, RFA, MWA, PEI, SBRT)
- Any systemic treatment within the past 3 months or any plan to administer systemic treatments during the study
- Endocrine therapy - any prior hormonal therapy for HCC
- Radiotherapy - any prior radiotherapy for HCC or any concurrent anticancer radiotherapy
- Surgery - major surgery/laparoscopy within 30 days before screening
- Investigational therapy - Patients who have participated in another clinical study within 12 weeks prior to the Screening/Baseline visit
- TACE therapy - Prior TACE on the same lesions
- Performance Status: ECOG ≥ 2 or KPS \< 80 at study entry
- Contraindication for both enhanced Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) imaging (according to patient characteristics and investigator decision).
- Any condition that would result in biliary ductal colonization including Whipple procedure, biliary stenting, a sphincterotomy within 3 month, hepatojejunostomy, etc.
- Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- Any absolute contra-indication to TACE, contraindication to angiography
- Any absolute contra-indication to doxorubicin according to its label
- Contraindication or known allergic reactions to contrast media agents, Radiopaque Beads or with known sensitivity to iodine/iodine containing substances.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03452553
Start Date
July 1 2018
End Date
October 30 2020
Last Update
April 21 2021
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