Interventional Oncology
EPOCH Trial
An international, multi-centre, open-label, phase III, randomised controlled trial to study the impact of TheraSphere™ Y-90 Glass Microspheres in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM)
Trial Information
- Study Objective
- Evaluate efficacy and safety of TheraSphere in patients with metastatic colorectal cancer of the liver, who had progressed on first line chemotherapy.
Trial Design
- Phase III, open label, multicentre (95 sites), prospective, 1:1 randomised trial
Unilobar or Bilobar Disease, KRAS Status (Mutant or Wild type, 1st Line Chemo (Irinotecan or oxaliplatin based)
Primary Endpoints
- PFS according to RECIST 1.1 from time of randomization to disease progression or death
- hPFS according to RECIST 1.1, from time of randomization to the date of disease progression in the liver or death
Secondary Endpoints
- Overall Survival (OS)
- Time to Symptomatic Progression (TTSP)
- Objective Response Rate (ORR)
- Disease Control Rate (DCR)
- Quality of Life Assessment
- Adverse Events and Reportable Serious Adverse Events