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:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT06752057
Brief Summary:
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
Detailed Description:
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
10 patients with advanced NSCLC progressed after first-line treatment will be recruited in this study. With doctor's assessment, a combined treatment of PD-1 inhibitor, radiotherapy, and personalized tumor neoantigen-loaded DC vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-loaded DC vaccine:
Collecting venous blood samples; Blood PBMC exome sequencing; RNA transcriptome sequencing; Classifying HLA alleles; Performing bioinformatics analysis, finding meaningful mutations and about 20 neoantigen sequences for each patient; Synthesizing neoantigens; Use a blood apheresis device to collect the patient's blood, isolate the PBMC needed to prepare DC cells, and return the remaining blood components to the patient's body (approximately 10\^9 cells will be collected);Preparation of the personalized tumor neoantigen-loaded DC vaccine.
Participants will receive a personalized radiotherapy treatment course, followed with PD-1 inihibitor injections (every 3 weeks) and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. After treatment, participants will be followed in every 6 weeks till the end of the study. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
Study:
NCT06752057
Study Brief:
Protocol Section:
NCT06752057