This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments therasphere, sorafenib
Phase phase 3
Sponsor BTG International Inc.
Collaborator Biocompatibles UK Ltd
Start date June 2013
End date June 2019
Trial size 328 participants
Trial identifier NCT01887717, 2012-005375-14, TS-104


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) in the treatment of patients with inoperable liver cancer and blockage of the portal vein.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
All patients in the Control group will receive SOC treatment with sorafenib in accordance with the package insert.
sorafenib Nexavar
standard of care therapy for treatment of advanced hepatocellular carcinoma
Patients will receive treatment with yttrium-90 microspheres in accordance with the package insert.
therasphere yttrium-90 microspheres
Treatment with TheraSphere

Primary Outcomes

time frame: from time of randomization up to 36 months

Secondary Outcomes

adverse events
time frame: from randomization up to 36 months
time to progression
time frame: from randomization up to 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients over 18 years of age, regardless of race of gender - Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis (confirmed by non-invasive criteria EASL/AASLD, mandatory by histology in non-cirrhotic patients); 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 CT or MRI according to RECIST 1.1 - ECOG Performance Status 0-1 - Platelets ≥ 50 X 10³/µL - WBC ≥ 1.5 X10³/µL - AST/ALT ≤ 5 X upper limit of normal - Creatinine ≤ 2.0 mg/dL - Life expectancy > 3 months - Signed informed consent Exclusion Criteria: - Confirmed extra hepatic metastases. Patients with indeterminate hepatic hilar lymph nodes up to 2.5 cm in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5 cm, or multiple smaller lesions with a total diameter ≤ 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, 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 TACE < 6 months prior to screening phase in case of patients progressing from an intermediate to an advanced stage due to occurrence of PVT - Patients cannot be 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 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 patient at undue risk and preclude safe use of TheraSphere treatment - Females of child-bearing potential must have a negative serum test Participation in concurrent clinical trials

Additional Information

Official title A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)
Principal investigator Vincenzo Mazzaferro, MD
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 patients with good hepatic function and advanced hepatocellular carcinoma (HCC) associated with portal vein thrombosis (PVT). This is an open-label prospective, multi-center, randomized, controlled clinical trial that will evaluate the use of TheraSphere compared to standard-of-care sorafenib alone.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by BTG International Inc..
Location data was received from the National Cancer Institute and was last updated in May 2016.