Status:
TERMINATED
Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Biocompatibles UK Ltd
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib...
Detailed Description
The objective of this Phase III, prospective randomized trial is to determine whether TheraSphere provides a meaningful benefit in survival in comparison with the standard of care (sorafenib) in parti...
Eligibility Criteria
Inclusion
- Participants over 18 years of age, regardless of race or gender
- Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis (confirmed by non-invasive criteria European Association for the Study of the Liver \[EASL\]/American Association for the Study of Liver Diseases \[AASLD\], mandatory by histology in non-cirrhotic participants); can be naive or recurrent HCC after curative treatment ( \>6 months before randomization)
- Unilobar disease
- Child Pugh A
- Tumor volume ≤70% of liver volume (determined by visual estimation)
- At least one uni-dimensional HCC target lesion assessable by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Platelets ≥ 50\*10\^3/microliter (µL)
- White blood cell (WBC) ≥1.5\*10\^3/microliter (µL)
- Aspartate transaminase (AST)/ alanine aminotransferase (ALT) ≤5 times upper limit of normal
- Creatinine ≤2.0 mg/deciliter (dL)
- Life expectancy \>3 months
- Signed informed consent
Exclusion
- Confirmed extra hepatic metastases. Participants with indeterminate hepatic hilar lymph nodes up to 2.5 centimeters (cm) in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5 cm, or multiple smaller lesions with a total diameter of ≤2 cm) may be included if metastatic disease is deemed unlikely
- Known contraindication to standard-of-care sorafenib including allergic reaction, pill swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, and renal failure including dialysis
- Evidence of hepatic vein invasion or caval thrombosis
- Evidence of chronic obstructive pulmonary disease
- Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
- Previous treatment with sorafenib for more than 4 weeks during the previous 2 months; prior sorafenib-related toxicity
- Initiation of anti-tumor therapy including chemotherapy or investigational drug treatment within 30 days before beginning study
- Prior transarterial chemoembolization (TACE) \<6 months prior to screening phase in case of participants progressing from an intermediate to an advanced stage due to occurrence of PVT
- On a transplant list
- History of organ allograft
- Contraindications to angiography or selective visceral catheterization
- History of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically
- Prior external beam radiation therapy to the liver
- Evidence of continuing adverse effect of prior therapy
- Active gastrointestinal (GI) bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents
- Evidence of any disease or condition that would place the participant at undue risk and preclude safe use of TheraSphere treatment
- Females of child-bearing potential must have a negative serum test
- No participation in concurrent clinical trials
Key Trial Info
Start Date :
February 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01887717
Start Date
February 27 2014
End Date
May 23 2017
Last Update
April 21 2021
Active Locations (19)
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1
Northwestern Medical Faculty Foundation, Div of Hematology/Oncology
Chicago, Illinois, United States, 60611
2
Mount Sinai School of Medicine
New York, New York, United States, 10029
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
4
Paoli-Calmettes Institute
Marseille, France, 13273