💬In plain words
What the trial is, and whether it could suit you
Patients with PVTT involvement is a significant healthcare burden as they are present in up to 40% of patients with HCC at diagnosis. These patients exhibit a poorer prognosis compared to patients without PVTT, as a result they were often excluded from existing pivotal clinical trials \[9-11\]. Without management, the median OS in affected patients could be as short as 2 to 4 months. The role of liver-directed therapies is limited for patients with major PVTT. For example, percutaneous ablation to PVTT is technically challenging, especially for centrally located PVTT due to their proximity to hepatic vasculature and bile ducts. Transarterial therapies are contraindicated for patients with major PVTT due to risk of concurrent interruption of both hepatic arterial and portal venous blood flow resulting in severe liver ischemia. Therefore, patients with major PVTT are recommended to receive
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
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