進行中(不再收案) NCT05873244

CXD101 用於免疫治療相關肝癌

肝癌食道癌Phase IIPD-L1

對於肝細胞癌 (HCC),以免疫檢查點抑制劑 (ICI) 為基礎的治療在臨床試驗中已報告有持久的緩解及改善的存活期。然而,在 HCC 患者的臨床實踐中,對 ICI 的抗藥性日益常見。 目前臨床上正評估各種方法以應對 HCC 患者接受 ICI 治療期間出現的後天抗藥性。 我們團隊在組蛋白去乙醯化

適應症:HCC

收案條件

納入條件

  • Diagnosis of HCC according to the AASLD guideline20
  • Prior treatment with systemic treatment consisting of immune checkpoint inhibitors (anti-PD1, anti-PDL1 or anti-CTLA4)
  • The duration of previous ICI must be 6 weeks or longer to avoid chance of pseudo-progression
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
  • Adequate hematological function:
  • Absolute neutrophil count (ANC) ≥ 1.5 x109/L; Platelets ≥ 100 x 109/L and Hemoglobin ≥ 8g/dL
  • Adequate renal function:
  • Urine protein/creatinine ratio ≤ 1 mg/mg (≤ 113.1 mg/mmol) or 24-hour urine protein \< 1g
  • Serum creatinine ≤ 1.5 × upper limit of normal or calculated creatinine clearance ≥ 40 mL/min (according to the Cockcroft-Gault equation)
  • Adequate hepatic function parameters:
  • Total bilirubin ≤ 2 mg/dL (≤ 34.2 μmol/L)
  • Serum albumin ≥ 2.8 g/dL (≥ 28 g/L)
  • Alanine aminotransferase (ALT) \< 3.0 upper limit of normal (ULN)

排除條件

  • Previous development of severe autoimmune complications from immune checkpoint inhibitors
  • History of moderate to sever autoimmune disease requiring steroid use
  • History of organ transplant
  • Prior use of lenvatinib or sorafenib
  • Disease involvement/thrombosis of major vessels (including main trunk of portal vein, inferior vena cava or pulmonary artery)
  • More than two lines of systemic therapy (i.e., study treatment must be second-line or third-line treatment)
  • Clinically significant bleeding events (eg.. esophageal varices) within 3 months
  • Moderate or severe ascites
  • Child-pugh B or C hepatic function
  • Systolic blood pressure of 200mmHg or higher
  • Pregnant or lactating females

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。