Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis

Inclusion criteria

• Clinical or histological diagnosis of HCC with bilateral PVTT;
• Estimated Liver-GTV volume < 700ml or the estimated volume of liver minus GTV volume receiving less than 5 Gy of irradiation < 300ml;
• Age 18-90 years;
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
• Child-Pugh A5, A6, B7 and B8;
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal (ULN); or ALT ≤ 1.5 times ULN and AST ≤ 6 times ULN; TBIL < 60umol/L.
• Creatinine (CRE) and blood urea nitrogen (BUN) < 2.5 ULN;
• Hb ≥ 50g/L, ANC ≥ 0.5 × 109/L, PLT ≥ 30 × 109 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L;

• Voluntary to participate and sign informed consent.

Exclusion criteria

• Participating in other clinical trials currently;
• The history of abdominal irradiation;
• The history of liver transplantation;
• Known allergy to tislelizumab or lenvatinib;
• Pregnant, breast feeding, or unwilling to use adequate contraception;
• Serious myocardial disease or renal failure;
• Other serious diseases, such as alcohol and drug abuse or mental illness;
• Presence of other life-threatening malignancy within the last 3 years before enrollment (excluding superficial skin cancer, localized low-grade malignant tumor and carcinoma in situ).