Clinical Evaluation of M1-c6v1 Oncolytic Virus Combined with Camrelizumab and Apatinib in Advanced Hepatocellular Carcinoma

PURPOSE: This study evaluated the safety, tolerability, and preliminary efficacy of M1-c6v1, an oncolytic virus, combined with the immune checkpoint inhibitors camrelizumab and the VEGFR2 inhibitor apatinib in advanced hepatocellular carcinoma (HCC). PATIENTS AND METHODS: This single-arm, investigator-initiated, open-label clinical trial enrolled patients with advanced HCC (NCT04665362). Patients received M1-c6v1 (9 × 108 cell culture infective dose 50%) intravenously for 5 days every 28 days, camrelizumab (200 mg) intravenously biweekly, and apatinib (250 mg) orally daily. Treatment continued for up to 1 year or until disease progression, intolerability, or withdrawal. Primary endpoints were safety and tolerability, and secondary endpoints assessed efficacy based on tumor response, progression-free survival, and overall survival. RESULTS: Thirteen patients were enrolled, with 84.6% having hepatitis B virus-related HCC and 76.9% presenting with tumors >10 cm. The treatment was well tolerated, with 92.15% of adverse events being grade 1 or 2. The most common adverse events included influenza-like symptoms and transient cytopenia. No viral shedding was detected in all secretions and excretions collected from subjects. In 10 patients evaluable for efficacy, the overall response rate was 70% (7/10), with seven partial responses according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). The median overall survival and progression-free survival were 15.4 and 8.9 months, respectively. CONCLUSIONS: The combination of M1-c6v1 with camrelizumab and apatinib demonstrates an acceptable safety profile and promising efficacy in advanced HCC.