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。