进行中(不再招募) NCT05873244

CXD101 用于免疫治疗相关肝癌

肝癌食管癌Phase IIPD-L1

对于肝细胞癌 (HCC),以免疫检查点抑制剂 (ICI) 为基础的治疗在临床试验中已报告有持久的缓解及改善的生存期。然而,在 HCC 患者的临床实践中,对 ICI 的耐药性日益常见。 目前临床上正评估各种方法以应对 HCC 患者接受 ICI 治疗期间出现的后天耐药性。 我们团队在组蛋白去乙醯化

适应症:HCC

入组条件

纳入标准

  • 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)

排除标准

  • 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

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。