Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VG161 in Combination With Nivolumab in Patients With Advanced Pancreatic Cancer
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).
• Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form
• Age 18 to 75 years (inclusive), male or female
• According to the Guidelines for the Diagnosis and Treatment of Pancreatic Cancer, patients with histologically or cytologically confirmed advanced primary pancreatic ductal adenocarcinoma, acinar cell carcinoma or adenosquamous carcinoma, accompanied by metastasis (TxNxM1), who have failed standard treatment, or have no effective treatment at this stage
• The presence of at least one intratumoral injection lesion with the longest diameter (the longest diameter of lymph nodes) greater than or equal to 1.5 cm that is required by the dose volume of the acceptable current dose group, including superficial lesions or deep lesions that can be injected under B ultrasound/CT guidance (such as liver metastases, etc.)
• Herpes simplex virus type I (HSV-1) antibody test results (HSV-1IgG or HSV-1IgM) are positive
• ECOG performance score 0-1
• The expected survival time is more than 3 months
• Adequate organ function: 1) blood routine (No blood transfusion or colony-stimulating factor treatment Within 14 days): ANC ≥ 1.5 × 10\^9/L, PLT ≥ 75 × 10\^9/L, Hb ≥ 90 g/L, lymphocyte count ≥ 1.5 × 10\^9/L (for lymphocyte count 1.0 × 10\^9/L to 1.5 × 10\^9/L, the investigator judges whether it is necessary); 2) liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN (patients with liver metastases can receive ALT ≤ 5 × ULN, AST ≤ 5 × ULN); 3) Child-Pugh score: A-B; 4) renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to CockftGault formula); 5) coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN
• Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after medication; female patients of childbearing age must have a negative blood pregnancy test 7 days before inclusion