About this trial
In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male or female
age>18 years old
with advanced or recurrent malignancies diagnosed by pathology and imaging, who have failed systemic standard therapy or disease progression prior to enrollment and have no effective first-line therapy (for effective therapy, refer to the latest version of the treatment guidelines published by the Chinese Society of Clinical Oncology)
have at least one imaging measurable lesion
Disqualifiers
No neoantigens detected in the sequencing data.
with a history of bone marrow or stem cell transplantation
enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine
with active bacterial or fungal infections
Trial design
Sequential
Treatments tested in this trial
Placebo + conventional treatment including radiotherapy
Other interventionPlacebo + conventional treatment including radiotherapy
Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccine
Combination productThe peptide vaccine treatment will take 5 months as a treatment course until the treatment suspension event as stipulated in the plan occurred.
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival
Number of participants with Adverse Events as a measure of safety and tolerability
Sponsors and contacts
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