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

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    888
  • sponsor
    AstraZeneca
Updated on 22 September 2021
bevacizumab
durvalumab

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.

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.

Details
Condition Adenocarcinoma, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment Placebo, bevacizumab, durvalumab
Clinical Study IdentifierNCT03847428
SponsorAstraZeneca
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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
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