This prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .
Age ≥18 years old, and ≤75 years old, regardless of gender;
Primary hepatocellular carcinoma confirmed by histology or imaging;
Patients with advanced hepatocellular carcinoma who have not received oncolytic viruses, immutherapy drugs (including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs), and systemic therapy (such as anti-VEGF /VEGFR monoclonal antibodies, anti- VEGFR-TKI drugs, chemotherapy);
ECOG performance status 0-1;
Pregnant or lactating women, men or women unwilling to use effective contraception;
Diffuse liver cancer or tumor is not suitable for RECIST 1.1 criteria;
Patients who have previously received an oncolytic viral agent such as T-VEC;
Known allergy to the study drug or its active ingredient, history of allergy to the same biological agent;