A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
- Trial number:
-
NCT03778957
- Trial phase:
- 3
- Study type:
- immunotherapy, targeted, local
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Key - No evidence of extrahepatic disease - Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE - Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment - Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria - Adequate organ and marrow function Key
- Any history of nephrotic or nephritic syndrome - Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization - Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion) - History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment - Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded