Clinical Trial on the Safety and Efficacy of Neoantigen Antigen mRNA Tumor Vaccine in the Treatment of Advanced Esophageal Cancer and Non-small Cell Lung Cancer
A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal cancer and non-small cell lung cancer
• Aged between 18 and 75 (including both ends), with no gender limit;
• The primary lesion was confirmed by histopathology or cytology as esophageal carcinoma (ⅢC (T4bNanyM0, TanyN3M0), and stage Ⅳ) or non-small cell lung cancer (stage ⅢB-Ⅳ).
• Patients who have metastatic or locally advanced tumor but failed instandard treatments or not suitable for standard treatments;
• According to RECIST (V1.1), the efficacy evaluation criteria for solid tumors, there is at least one measurable lesion.
• Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS
• Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry
• Fertile patients must agree to use a reliable contraceptive methods (hormonal or barrier methods or abstinence) during the trial and for at least 12 weeks after the last treatment;
• The subject voluntarily participates and signs ICF (Informed consent forms).