Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01883518
Brief Summary:
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
Detailed Description:
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.
Study:
NCT01883518
Study Brief:
Protocol Section:
NCT01883518