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

Trial number:
NCT03847428
Trial phase:
3
Study type:
Immunotherapy, Targeted therapy
Overall status:
Active, not recruiting

Study start date

April, 2019

Scientific title

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

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.

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 HCCEvidence 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

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Quadruple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes, Outcomes assessor masked: Yes,

Conditions

Hepatocellular Carcinoma

Other study ID numbers

D910DC00001; 2018-004105-85

Choose trial site (486)

National University Hospital 119074
National University Hospital 119074 Not yet recruiting
5 Lower Kent Ridge Rd, Singapore 119074
Tan Tock Seng Hospital Singapore
Tan Tock Seng Hospital Singapore Not yet recruiting
11 Jln Tan Tock Seng, Level 1, Singapore 308433
Curie Oncology (Novena)
Curie Oncology (Novena) Recruiting
38 Irrawaddy Rd, #05-43, 50 to 55, Singapore 329563