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A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
Active Not RecruitingPhase 3
Sponsor: AstraZeneca
Conditions: Hepatocellular Carcinoma
Interventions: Durvalumab, Bevacizumab, Placebo, Transarterial Chemoembolization (TACE)
Countries: United States, Australia, Brazil, Canada, China, France, Hong Kong, India
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Eligibility overview
Sex: ALL
Age: 18 Years to 110 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Key Inclusion Criteria: * 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 Exclusion Criteria * 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
Locations (166)
- Costa Mesa, California, United States
- La Jolla, California, United States
- Orange, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Shreveport, Louisiana, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Stony Brook, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
- Benowa, Australia
- Box Hill, Australia
- Camperdown, Australia
- Clayton, Australia
- Herston, Australia
- Liverpool, Australia
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