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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03847428

This Phase III, double-blind study evaluates durvalumab with or without bevacizumab as adjuvant therapy in HCC patients post-curative treatment. Eligible participants must have confirmed HCC, disease-free status, ECOG 0-1, Child-Pugh score 5-6, and adequate organ function. Interventions include durvalumab, bevacizumab, or placebo administered intravenously.

Patient Parameters

Program Overview

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.

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.

Eligibility 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

Locations

FACILITYZIPCITYSTATE
Research Site35233BirminghamAlabama
Research Site36604MobileAlabama
Research Site85054PhoenixArizona
Research Site92627Costa MesaCalifornia
Research Site92093-0698La JollaCalifornia
Research Site90806Long BeachCalifornia
Research Site92868OrangeCalifornia
Research Site95817SacramentoCalifornia
Research Site20007Washington D.C.District of Columbia
Research Site33176MiamiFlorida

Get This Program In Your Inbox

You can sign up and apply your patients for this program.