NCT06434376

MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis

Study on Adjuvant Treatment of MRD-positive Colorectal Cancer Patients With Routine Chemotherapy Combined With Personalized Immune Regulation Diagnosis and Treatment Technology

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy: Patients with MRD positive and high risk of recurrence after colorectal cancer surgery were enrolled. Surgical tumor tissue and blood samples were collected, tumor tissue samples were sequenced, neoantigens were analyzed, personalized immunomodulators were prepared, and routine adjuvant therapy combined with personalized immunomodulatory diagnosis and treatment technology were performed to prevent postoperative recurrence. To establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology	Blood samples were collected for MRD detection within one month (week 3) after colorectal cancer surgery, and MRD-positive patients were selected for routine chemotherapy (course of 6 months). Blood and tumor tissue samples of enrolled patients were collected, and relevant clinical data were recorded. The whole exon and expression profile of surgical tumor tissue samples were sequenced, neoantigens were analyzed, and immunomodulators were prepared. After the preparation of individualized immunomodulators, combined treatment was performed simultaneously with chemotherapy. During the treatment process, patients' response to treatment and survival were observed, and tumor load, ctDNA changes, imaging and other indicators before and after treatment were compared. To evaluate the efficacy of immunotherapy.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-07-01
• Completion: 2026-12-31
• First posted: 2024-05-30
• Last updated: 2024-05-30