A Study to Assess the Effectiveness and Safety of Durvalumab Alone or Combined with Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

Overview

About this study

The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Histologically or cytologically confirmed Hepatocellular Carcinoma (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 Hepatocellular Carcinoma (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 both HBV and HCV, or co-infected with HBV and hepatitis D virus.
  • Receipt of prior systemic anticancer therapy for HCC.
  • Those on a waiting list for liver transplantation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Kabir Mody, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Sonbol, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Sean Cleary, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20472610

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