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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

NCT03778957

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
  • + 136 more on CT.gov