VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection.This study will be conducted in combination with camrelizumab in patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. This is an open-label study divided into two parts.
Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.
Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.
Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
Age 18 to 75 (inclusive), gender is not limited.
Patients with advanced primary hepatocellular carcinoma confirmed by histopathology or cytology.
According to the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition), patients who have received at least previous first-line treatment regimens that have failed treatment (disease progression or inability to tolerate treatment) must have been treated.
Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma or mixed hepatocellular carcinoma.
Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).
Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.
Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.