进行中(不再招募) NCT03383458

Nivolumab 用于根治性肝切除或消融后高复发风险肝细胞癌参与者的研究

肝癌胆道癌肉瘤Phase III

本研究将探讨 nivolumab 对比安慰剂,能否改善已接受完全切除或局部消融后达完全缓解、且具高复发风险之肝细胞癌(HCC)参与者的无复发生存期(RFS)。

适应症:Hepatocellular Carcinoma、Liver Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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
  • Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。