Hepatocellular Carcinoma
Conditions
Keywords
Early stage HCC, Durvalumab, Bevacizumab, Liver Cancer
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.
Interventions
DRUGDurvalumab
Durvalumab IV (intravenous)
DRUGBevacizumab
Bevacizumab IV (intravenous)
OTHERPlacebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 150 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| 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) |
Countries
Australia, Austria, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, India, Italy, Japan, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States, Vietnam
Contacts
PRINCIPAL_INVESTIGATORJia Fan, PhD
Liver Cancer Institute Zhongshan Hospital, Fudan University
PRINCIPAL_INVESTIGATORJennifer Knox, MD
Solid Tumor Medical Oncology Princess Margaret Cancer Centre
Outcome results
None listed