招募中 NCT06885879

放射治疗对肝细胞癌患者 ctDNA 的影响

肝癌胆道癌肉瘤不适用

放射治疗在肝细胞癌(HCC)的治疗中日益被用作单独治疗或与全身治疗联合使用。立体定向身体放射治疗(SBRT)会直接(通过双链断裂)及间接(通过血管床损伤或促进抗肿瘤免疫)导致细胞死亡。可惜的是,细胞死亡的效果并非即时,需要时间。

适应症:HCC - Hepatocellular Carcinoma

入组条件

纳入标准

  • Patients aged ≥ 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance 0 to 1
  • Confirmed diagnosis of Hepatocellular carcinoma (HCC)
  • Tumour size ≥ 3cm
  • Patients planning on undergoing Stereotactic Body Radiation Therapy (SBRT) for HCC
  • Prior radiofrequency ablation at a different site, or prior surgery are eligible
  • Child-Pugh A liver function
  • Life expectancy longer than 12 weeks
  • At least one measurable treatment lesion according to RECIST 1.1
  • Written informed consent must be obtained prior to any study related procedures
  • Adequate haematological function (Hemoglobin ≥ 8.5g/dL; Platelet Count ≥ 75x109/L; Antenatal Care ≥ 1.5x109/L; international normalised ratio ≤ 1.5)
  • Adequate hepatic function (albumin ≥ 28g/l; Bilirubin ≤ 1.5xULN; Alanine transaminase \< 5 times upper limit normal)
  • Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Sodium ≥ 130mmol/L; Potassium ≥ 3.0mmol/L)
  • Able to read, understand and provide written consent

排除标准

  • Histology shows sarcomatoid HCC, fibrolamellar HCC, mixed cholangiocarcinoma-hepatocellular carcinoma
  • Presence of other malignancy than HCC within 5 years from diagnosis of HCC
  • Prior Transarterial chemoembolization (TACE) within 3 months
  • Previous radiotherapy to the abdomen
  • Previous yttrium-90 chemoembolization
  • Repetitive history of non-healing wounds or ulcers within 2 months of inclusion
  • Pregnant or lactating females at any time during the study
  • Active autoimmune disease requiring systemic therapy in the past 2 years
  • Diagnosis of immunodeficiency (including Human Immunodeficiency Viruses)
  • Patients with coagulopathy or on anticoagulant will be excluded from liver biopsy

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。