Sarcoma Clinical Trial
Official title:
Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma
The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas
Vaccination is carried out on the planned days ± 3 days
1. All examinations must be performed before the vaccine is administered.
- Full physical examination.
- Assessment of vital signs (blood pressure, temperature, heart rate), the general
condition of the patient and physical activity.
- Evaluation of concomitant therapy.
- Assessment of vital signs.
- Laboratory safety and immunological indicators
- Assessment of adverse events, symptoms and syndromes of the disease.
2. Introduction of CV in accordance with the dose determined for a given vaccination (see
section 9.2. - procedures for delivery and use)
3. After administration, patients are observed for at least 1 hour. An assessment of vital
indicators. Undesirable effects detected at the introduction are recorded.
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