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D910DC00001: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Overall Recruitment Status: Active, currently enrolling
 
Official Title
D910DC00001: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
 
Region Sponsors
Hawaii
AstraZeneca
 
Acronym KP IRB No.
EMERALD2 1551558-1
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
 
Purpose
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.
 
Detailed Description
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Histologically or cytologically 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
 
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
  • Evidence of portal vein thrombosis
  • Receipt of prior systemic anticancer therapy for HCC
  • Those on a waiting list for liver transplantation

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Carney, MD
Contact Information:
- Shelley Clark, RN
-Moanalua Medical Center and Clinic


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