Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT03847428
- Lead Sponsor
- AstraZeneca
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 908
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Placebo Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W) Arm C Placebo Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W) Arm A Durvalumab Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W) Arm B Durvalumab Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W) Arm A Bevacizumab Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
- Primary Outcome Measures
Name Time Method Recurrence-free survival (RFS) for Arm A vs Arm C Up to 49 months after first patient randomized RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Recurrence-free survival (RFS) Arm B vs Arm C Up to 49 months after first patient randomized RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C Up to 49 months after first patient randomized Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C No timeframe OS is defined as the time from the date of randomization until death due to any cause
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C Up to 49 months after first patient randomized TTR is defined as the time from the date of randomization until the date of disease recurrence
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C At 24 and at 36 months Proportion of RFS at 24 months and at 36 months
Trial Locations
- Locations (1)
Research Site
🇻🇳Hochiminh, Vietnam