Her1 vaccine in metastatic colon and prostate cancer
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/94899
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Interventions: All patients included in the study will be treated with the HER1 vaccine.
Dose: Initially 2 dose levels (400µg and 800µg) will be opened in each stratum (prostate and colon). In the event of closure of both dose levels due to some stop criteria, another dose (1200 µg) will be opened.
Route of administration: Intramuscular.
Treatment frequency: Every 14 days during the first five administrations (approximately 2 months) and subsequently, every 28 days for the remaining ten immunizations, until discontinuation for any of the reasons provided for in the research protocol or upon completion of 12 months of treatment. .
The treatment period will be 336 days, approximately 12 months.;ErbB Receptors;Vaccines;Injections, Intramuscular;HER1, therapeutic vaccine
Primary outcome(s): Proportion of patients with serious adverse events with a causal relationship (according to CTCAE criteria and causality criteria: SAE with very probable, probable or possible causation). Measurement time: at all times of administration of the research product.
Study Design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
创建时间:
2023-11-15



