涉及 PVTT 的患者構成重大醫療負擔,因為在診斷時多達 40% 的 HCC 患者會出現此情況。與無 PVTT 的患者相比,這些患者預後較差,因此他們常被排除於現有的關鍵臨床試驗之外 \[9-11\]。若不加以處理,受影響患者的中位 OS 可短至 2 至 4 個月。
適應症:HCC
收案條件
納入條件
- Patients aged ≥ 18 years old
- ECOG performance 0 to 1
- Confirmed diagnosis of HCC (either histologic or cytologic analysis, or clinical features according to the American Association for the Study of Liver Diseases)
- Presence of major portal vein thrombosis (Vp3 \[first-order tumour thrombosis in portal vein\] or Vp4 \[tumour thrombosis in the main portal vein, or portal vein branch in contralateral lobe\]), limited to the liver and should be amenable to SBRT
- No disease progression after 2 cycles of atezolizumab plus bevacizumab
- Presence of ≤5 lesions within the liver
- Gastric or esophageal varices must be screened; if interventions were performed, repeated upper endoscopy is needed to confirm healing of treated varices
- Child-Pugh A liver function
- Life expectancy longer than 3 months
- At least one measurable treatment lesion according to RECIST 1.1
- Extrahepatic metastases are allowed, limited to 3 sites, and not causing functional compromise
- Written informed consent must be obtained prior to any study related procedures
- Adequate haematological function (Hb ≥ 8.5g/dL; Plt ≥ 75x109/L; ANC ≥ 1.5x109/L; INR ≤ 1.5)
- Adequate hepatic function (albumin ≥ 28g/L; Bilirubin ≤ 40 μmol/L; ALT \< 5 times upper limit normal)
- Adequate renal function (serum creatinine ≤ 2 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L)
- Able to read, understand and provide written consent
排除條件
- History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
- History of rupture HCC in the past 3 months
- History of gastric or esophageal varices with interventions performed within 1 month
- Tumour thrombosis that extends beyond the portal vein (e.g. inferior vena cava, superior vena cava)
- Liver tumours occupy ≥ 50% of liver
- 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 HIV)
- Ongoing corticosteroid therapy \>10mg prednisone daily
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。