TheraSphere® Clinical Trials


BTG is currently conducting three Clinical Trials with TheraSphere®.

Please consult www.clinicaltrials.gov under the name TheraSphere® for official clinical trial information.

EPOCH (TS-102): A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy.
Principal Investigator:
Mary Mulcahy, MD Northwestern Hospital, Chicago (US)
Ricky Sharma, MA FRCP FRCR PhD Oxford University, Oxford (UK)
 
Study Objective:
To evaluate the efficacy and safety of TheraSphere® in patients with metastatic colorectal cancer (mCRC) of the liver scheduled to receive second line chemotherapy.
 
Estimated Enrollment:
340 patients
 
Estimated Sites Worldwide:
100
 
Stratification:
Unilobar or bilobar oxaliplatin or irinotecan 1st line KRAS status.
 
ClinicalTrials.gov Identifier:  
NCT01483027
 
Study Website: http://www.theraspheretrials.com 
STOP-HCC (TS-103): A Phase III Clinical Trial of Intra‑arterial TheraSphere® in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC).
Principal Investigator:
Riad Salem, MD, MBA Northwestern Hospital Chicago (US)
 
Study Objective:
To evaluate the efficacy and safety of TheraSphere® in patients with unresectable hepatocellular carcinoma in whom standard of care with sorafenib is planned.
 
Estimated Enrollment:
390 patients
 
Estimated Sites Worldwide: 
105
 
Stratification: 
Region (North America + Europe or Asia) ECOG 0 vs 1 Presence of PVT vs Absence of PVT. 
 
ClinicalTrials.gov Identifier:
NCT01556490 
 
Study Website:  
http://www.theraspheretrials.com 
 
YES-P (TS-104): Phase III, open label, prospective, multi‑center, 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, PhD Istituto Nazionale Tumori, Milan
Riad Salem, MD, MBA Northwestern Hospital, Chicago
 
Study Objective:
To assess efficacy and safety of TheraSphere® in comparison to sorafenib in the treatment of patients with portal vein thrombosis associated with unresectable hepatocellular carcinoma.
 
Estimated Enrollment:
320 patients to maximum 500
 
Stratification:
AFP (≤ 400 ng/ml vs > 400 ng/ml) Trial site
 
ClinicalTrials.gov Identifier:
NCT01887717
 
Study Website:
http://www.theraspheretrials.com
 


For further information, please consult with Clinical Affairs, BTG TheraSphereClinical@btgplc.com.

TheraSphere® is authorized by Federal Law (USA) for use as a humanitarian device in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated.

All relevant regulatory requirements for the study of an investigational device will be met in all countries in which the above-noted trials will be conducted. In particular, the STOP-HCC and EPOCH trials will be conducted under an Investigational Device Exemption (IDE) approved by the FDA, and will comply with all FDA and institutional review board requirements.