drugset / Trial / NCT07504484

Safety and Efficacy of Neoantigen-Based Personalized Immunotherapy as Consolidation Therapy After Standard Adjuvant Treatment in Resectable Stage III Colorectal Cancer or Non-Small Cell Lung Cancer

NCT07504484

NaSingle-groupOpen-labelPrevention

Summary

The primary objective of this study is to evaluate the safety, efficacy, and methodological feasibility of sequential administration of neoantigen-based personalized immunotherapy following completion of standard adjuvant therapy in patients with colorectal cancer or non-small cell lung cancer who have undergone radical resection. Based on previous safety clinical trial results of personalized anti-tumor neoantigen injections, the 300 μg/peptide dose is well tolerated. Therefore, this study will assess the safety and preliminary efficacy of personalized anti-tumor neoantigen injections at a dose of 300 μg/peptide as consolidation therapy after standard postoperative adjuvant treatment in patients with stage III resectable colorectal cancer or non-small cell lung cancer, aiming to provide novel personalized therapeutic strategies to improve disease-free survival (DFS) and overall survival (OS) in these patients.

Timeline

Start
2020-10-30
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Neoantigen Peptides Vaccine 300 ug Subcutaneous
Background sargramostim Protein / enzyme biologic 40 ug Subcutaneous