招募中 NCT07305428

使用免疫治疗和立体定向射束放射治疗联合将不可切除的肝细胞癌降级为可切除的疾病:试点研究

肝癌胆道癌不适用III 期IV 期

肝细胞癌( HCC )是全球最常见的癌症之一,在癌症相关死亡发生率方面排名第三。全球每年诊断出超过500000例新病例。HCC的发病率和患病率呈上升趋势,大多数疾病负担在病毒性乙型肝炎流行的亚洲。

适应症:HCC - Hepatocellular Carcinoma、Unresectable Hepatocellular Carcinoma

入组条件

纳入标准

  • 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

排除标准

  • 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

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。