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ROWAN: An Open-Label, Prospective, Multi-Center, Randomized Clinical Trial To Evaluate The Efficacy and Safety Of TheraSphereTM followed by Durvalumab (Imfinzi®) With Tremelimumab, Versus TheraSphereTM Alone For Hepatocellular Carcinoma (HCC).
Status: Recruiting
We are studying a treatment for people who have hepatocellular carcinoma that will be treated with TheraSphere™, a device that delivers radiation directly to the tumor. The study will determine if adding immunotherapy medications after TheraSphere™ treatment is safe and can improve results.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• not a candidate for liver resection, thermal ablation, or transplantation
• not able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• body weight >30 kg (66 lbs) and BMI ≥18 kg/m2
• must use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• metastasis of the cancer outside the liver
• history or organ or bone marrow transplant
• active or prior documented autoimmune or inflammatory disorders
• women who are pregnant or breastfeeding and who do not want to stop breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions:
Cancer
Keywords:
HCC, Hepatocellular cancer, Liver Cancer
Study Contact: Deb Mailand - mailand@umn.edu
Principal Investigator: Siobhan Flanagan
Phase: PHASE2
IRB Number: STUDY00016193
See this study on ClinicalTrials.gov