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

Inclusion Criteria:

1. Clinical or histological diagnosis of HCC with bilateral PVTT;
2. Estimated Liver-GTV volume \< 700ml or the estimated volume of liver minus GTV volume receiving less than 5 Gy of irradiation \< 300ml;
3. Age 18-90 years;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
5. Child-Pugh A5, A6, B7 and B8;
6. 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.
7. Creatinine (CRE) and blood urea nitrogen (BUN) \< 2.5 ULN;
8. 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;

10\. Voluntary to participate and sign informed consent.

Exclusion Criteria:

1. Participating in other clinical trials currently;
2. The history of abdominal irradiation;
3. The history of liver transplantation;
4. Known allergy to tislelizumab or lenvatinib;
5. Pregnant, breast feeding, or unwilling to use adequate contraception;
6. Serious myocardial disease or renal failure;
7. Other serious diseases, such as alcohol and drug abuse or mental illness;
8. 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).