Clinical Trial

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

Completed Phase 1
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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.
Trial Details
NCT Number NCT07504484
Lead Sponsor Ying Yuan, MD
Collaborators: Hangzhou Neoantigen Therapeutics Co., Ltd.
Conditions CRC (Colorectal Cancer), Non Small Lung Cancer
Enrollment 6 participants
Start Date 2020-10-30
Primary Completion 2023-12-31 (estimated)
Study Completion 2023-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-31