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Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

NCT03847428

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Hepatocellular Carcinoma

Interventions: Durvalumab, Bevacizumab, Placebo

Countries: United States, Australia, Austria, Brazil, Canada, China, Egypt, France

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Eligibility overview

Sex: ALL

Age: 18 Years to 150 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
* Imaging to confirm disease-free status within 28 days prior to randomization
* ECOG 0-1 at enrolment
* Child-Pugh score of 5 or 6
* Adequate organ and marrow function.

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
* History of hepatic encephalopathy within 12 months prior to randomization
* Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
* Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
* Active co-infection with HBV and HDV.
* Receipt of prior systemic anticancer therapy for HCC
* Those on a waiting list for liver transplantation
Locations (217)
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Costa Mesa, California, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • Washington D.C., District of Columbia, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Honolulu, Hawaii, United States
  • Chicago, Illinois, United States
  • Westwood, Kansas, United States
  • Louisville, Kentucky, United States
  • Shreveport, Louisiana, United States
  • Detroit, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Rochester, Minnesota, United States
  • Omaha, Nebraska, United States
  • New Brunswick, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • Stony Brook, New York, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Spartanburg, South Carolina, United States
  • + 187 more on CT.gov