NCT06751940

Neoantigen-loaded DC Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment

A Multicenter Clinical Study of Personalized Tumor Neoantigen-loaded DC Vaccine Combined with Conventional Second-line Therapy for the Treatment of Colorectal Cancer Progressed After First-line Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded DC vaccine and conventional second-line therapy to patients with colorectal cancer (CRC) 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 CRC progressed after first-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional second-line therapy 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 conventional second-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.

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Conventional second-line therapy	Conventional second-line therapy includes chemotherapy, targeted cancer drugs, and/or PD-1 inhibitors.The chemotherapy drugs, dosage and treatment cycle are determined by the subject's attending physician based on the subject's specific conditions. The medication, dosage and treatment cycle of targeted cancer drugs will be determined by the subject's attending physician based on the subject's specific circumstances. The PD-1 inhibitor treatment cycle is 3 weeks, and the drug is administered by intravenous infusion on the first day (D1) of each treatment cycle. The dosage is based on the instructions.
DRUG	Neoantigen-loaded DC vaccine	The treatment with personalized tumor neoantigen-loaded DC vaccine is divided into two periods: the primary phase and the boost phase. The primary phase consists of 6 treatments, with the first 3 treatments spaced one week apart and the subsequent 3 treatments spaced two weeks apart. Vaccine will be administrated on the fourth day (D4) of that week. The boost phase consists of 4 treatments, each spaced three weeks apart. Vaccine will be administrated on the fourth day (D4) of that week.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-31
• Completion: 2027-02-28
• First posted: 2024-12-30
• Last updated: 2024-12-30

Locations

2 sites across 1 country: China