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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
6
iNeo-Vac-P01 employs neoantigen peptides to activate the body's immune system, thereby eliminating residual tumor cells after surgery and preventing tumor recurrence and metastasis, enabling patients to derive greater benefit from personalized immunotherapy. For iNeo-Vac-P01, an innovative personalized immunotherapy based on neoantigens, the administration regimen is as follows: Personalized anti-tumor neoantigen injection (300 μg/peptide) plus GM-CSF (40 μg per injection site) will be administered via subcutaneous injection at multiple sites (around the upper arms and abdomen). Five priming immunizations will be given on Days 1, 4, 8, 15 ± 3, and 22 ± 3. Booster immunizations will be administered on Days 52 ± 7 and 82 ± 7. Additional booster doses may be given at 2-month intervals based on the subject's clinical benefit.
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Safety and Tolerability Parameters:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of patients with clinical or laboratory adverse events (AEs) will be evaluated over a 7-month assessment period. Assessment items include: vital signs, complete blood count, urinalysis, serum electrolytes, liver function, renal function, coagulation function, cytokines, and C-reactive protein (CRP).
Time frame: 7 months
1-Year Recurrence-Free Survival Rate
Assessment method: Contrast-enhanced CT/MRI imaging: Every 2 months for the first 12 months; Every 3 months for the subsequent 12 months. If disease progression is determined according to RECIST v1.1 criteria, the clinician will decide whether to continue treatment based on whether the patient's clinical symptoms have improved and whether clinical benefit is achieved.
Time frame: 1 year
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