招募中 NCT06885879

放射治療對肝細胞癌患者 ctDNA 的影響

肝癌膽道癌肉瘤不適用

放射治療在肝細胞癌(HCC)的治療中日益被用作單獨治療或與全身治療聯合使用。立體定向身體放射治療(SBRT)會直接(透過雙鏈斷裂)及間接(透過血管床損傷或促進抗腫瘤免疫)導致細胞死亡。可惜的是,細胞死亡的效果並非即時,需要時間。

適應症:HCC - Hepatocellular Carcinoma

收案條件

納入條件

  • 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

排除條件

  • 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

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。