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Szukaj Study Connect

Active, Not Recruiting

A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation - CA209-9DX

Zaktualizowano: 15 listopad, 2023   |   ClinicalTrials.gov

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Szczegóły badania

  • Phase 3

    Etap

  • Płeć

  • 18+

    Zakres wieku

  • Active, Not Recruiting

Opcje leczenia

Grupy badania
PRZYPISANA INTERWENCJA
Experimental: Arm A
Biological: Nivolumab
Placebo Comparator: Arm B
Other: Placebo

Kluczowe kryteria kwalifikacyjne

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants with a first diagnosis of HCC who have undergone a curative resection or ablation - Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC - Child-Pugh Score 5 or 6 - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Any evidence of tumor metastasis or co-existing malignant disease - Participants previously receiving any prior therapy for HCC, including loco-regional therapies - Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation Other protocol defined inclusion/exclusion criteria could apply