TheraSphere® Clinical Trials

 

BTG is currently conducting three Clinical Trials with TheraSphere®.
Please consult www.theraspheretrials.com or 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: 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: 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: www.theraspheretrials.com