招募中 NCT07305428

使用免疫治療和立體定向射束放射治療聯合將不可切除的肝細胞癌降級為可切除的疾病:試點研究

肝癌膽道癌不適用III 期IV 期

肝細胞癌( HCC )是全球最常見的癌症之一,在癌症相關死亡發生率方面排名第三。全球每年診斷出超過500000例新病例。HCC的發病率和患病率呈上升趨勢,大多數疾病負擔在病毒性乙型肝炎流行的亞洲。

適應症:HCC - Hepatocellular Carcinoma、Unresectable Hepatocellular Carcinoma

收案條件

納入條件

  • Diagnosis of HCC is made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule \>1cm and demonstrated in a single contrast enhanced dynamic imaging \[either computed tomography (CT) or magnetic resonance imaging (MRI)\] of intense arterial uptake and "washout" in portal venous and delayed phases.
  • Tumor size 5-25 cm or number of lesions ≤3 or segmental portal vein involvement
  • Age: 18-80 years old
  • Child Pugh liver function class A-B7
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

排除條件

  • Prior invasive malignancy
  • Prior radiotherapy to the region of liver or selective internal radiotherapy
  • Severe, active co-morbidity
  • Presence of extra-hepatic metastases (M1)
  • Main portal vein or inferior vena cava (IVC) thrombosis or involvement
  • Presence of ascites or encephalopathy
  • Contraindicated of SBRT:
  • Any one hepatocellular carcinoma \> 15 cm
  • Total maximal sum of hepatocellular carcinoma \> 25 cm
  • More than 3 discrete hepatic nodule
  • Direct tumor extension into the stomach, duodenum, small bowel, large bowel, common or main branch of biliary tree

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。