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;
Single group
Recombinant Human Adenovirus Type 5
DrugRecombinant Human Adenovirus Type 5( H101 )was administered intratumorally on day 1 and 5 of cycle 1 and cycle 2. If the sum of the maximum diameters of the lesions was less than or equal to 10 cm, the total dose was 1.0×10\^12 vp . If the sum of the maximum diameters of the lesions was more than 10 cm, the total dose was 1.5×10\^12 vp. Recombinant Human Adenovirus Type 5 was diluted to 30% of the total tumor volume with normal saline before administration. Under the guidance of ultrasound, percutaneous puncture was performed to the center of the tumor, and the solution was uniformly injected into the tumor. If there are multiple lesions, the distribution of each lesion should be proportional to the size of the tumor. No more than 5 lesions.
Lenvatinib
DrugLenvatinib was administered orally once daily started on day 1 of cycle 1 of the study until disease progression or unacceptable toxicity occurred or meet the end point of the study. For patients weighing less than 60 kg, the recommended daily dose was 8 mg once daily. For patients weighing ≥60 kg, the recommended daily dose was 12 mg once daily
Tislelizumab
DrugTislelizumab 200mg was administered intravenously every 3 week started on day 1 of cycle 3 until disease progression or unacceptable toxicity occurred or meet the end point of the study.
Objective response rate using RECIST v1.1
ORR is defined as the proportion of patients who have a partial or complete response to therapy
DOT
Duration of treatment
DOR
Duration of response
DCR
Disease control rate
PFS
progression-free survival
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