Cancer Clinical Trial
Official title:
PhaseI Trial of Tumor Neoantigen Vaccine
Despite years of preclinical efforts and hundreds of clinical studies, therapeutic cancer vaccines with the routine ability to limit or eliminate tumor growth in humans have been elusive. With advances in genome sequencing, it is now possible to identify a new class of tumor-specific antigens derived from mutated proteins that are present only in the tumor. These "neoantigens" should provide highly specific targets for antitumor immunity. Although many challenges remain in producing and testing neoantigen-based vaccines customized for each patient, a neoantigen vaccine offers a promising new approach to induce highly focused antitumor T cells aimed at eradicating cancer cells
1. Methods of vaccine storage and transportation: as a special biological product, the
vaccine should be stored at 2-8 ℃ to protect the efficacy (titer) of the vaccine from
being damaged.All vaccines must be stored and transported at temperatures that meet
regulatory requirements.A cold chain system is required to support and monitor the
temperature at all stages of the vaccine from production to final inoculation (aircraft,
ship, train, automobile, motorcycle, bicycle, walking, etc.);Cold storage, refrigerator,
vaccine transport box, cold pack, ice bar, etc.) to avoid overheating or over-cooling.
2. Treatment plan: intramuscular injection of vaccines of D1, D4, D7, D14, D21, D51, D142
of the deltoid muscle of the left and right upper arm, every six months for the next 3
years, and every year for the next 3 years, until the patient withdrew from the clinical
study or the study was discontinued.
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