Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 9:32 AM
Study NCT ID:
NCT06751966
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoantigen-based Peptide Vaccine and Conventional Third-line Therapy for CRC Progressed After Second-line Treatment
Sponsor:
The First Affiliated Hospital of Nanchang University
Organization:
Study Overview
Official Title:
A Multicenter Clinical Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with Conventional Third-line Therapy for the Treatment of Colorectal Cancer Progressed After Second-line Treatment
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine and conventional third-line therapy to patients with colorectal cancer (CRC) progressed after second-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 CRC progressed after second-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional third-line therapy and personalized tumor neoantigen-based peptide vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-based peptide 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 peptide neoantigens; Preparation of the personalized tumor neoantigen-based peptide vaccine.
Participants will receive a conventional third-line therapy course 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.
10 patients with CRC progressed after second-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional third-line therapy and personalized tumor neoantigen-based peptide vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-based peptide 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 peptide neoantigens; Preparation of the personalized tumor neoantigen-based peptide vaccine.
Participants will receive a conventional third-line therapy course 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: