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

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Bevacizumab; Durvalumab

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