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

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Centre 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

Summary:

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.

Trial Description

Primary Outcome:

• Recurrence-free survival (RFS) for Arm A vs Arm C

Secondary Outcome:

• Recurrence-free survival (RFS) Arm B vs Arm C
• Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
• Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
• Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
• Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C

This is a Phase III, randomized, double-blind, placebo-controlled, multi-centre, 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.

View this trial on ClinicalTrials.gov