A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Head and Neck Cancer
9 participants are expected to be enrolled for this open，single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.
• Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.
• Age 18 to 75 years.
• No absolute or relative centasis contraindiction，have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.
• No severe functinonal falure of heart, brain, liver, kidney and lung.
• Subjects with ECOG score of 0-2, and expected survival of 3 months or more.
• No evidence of clinically significant immunosuppression.
• Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period:
‣ White Blood Cell (WBC)≥3.0×10\^9/L；
⁃ Absolute Lymphocyte Count (ANC)≥1.5×10\^9/L;
⁃ Platelet≥100×10\^9/L；
⁃ Prothrombin time (PT) or activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
⁃ Serum Creatinine (Scr)≤1.5×ULN
⁃ Alanine aminotransferase(AST/ALT) ≤3×ULN;
⁃ Total Bilirubin(TBIL)≤1.5×ULN.
• Be able to understand and sign the informed consent document;
• Be able to stick to follow-up visit plan and other requirements in the agreement.