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

Prior treatment

• New lesions detected on imaging after completion of postoperative adjuvant therapy;
• Received immunotherapy or other investigational medicinal products prior to surgery;
• No actionable neoantigens identified for personalized immunotherapy after analysis of sequencing data;
• Prior history of bone marrow transplantation or stem cell transplantation;
• Concomitant use of any other anti-tumor drugs, anti-tumor therapies in other clinical trials, immunosuppressive agents, or long-term systemic glucocorticoids;
• Received any other vaccination within 4 weeks before treatment; Infection with HIV, HCV, or HBV; severe asthma; autoimmune disease or immunodeficiency; or immunosuppressed status (excluding vitiligo, type 1 diabetes, autoimmune hypothyroidism requiring hormonal therapy, and psoriasis not requiring systemic treatment);
• Drug abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study;

Other illness

• Poor general condition unsuitable for surgery or postoperative adjuvant therapy;
• Presence of other malignancies, except for cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia, etc., and those who have been disease-free for more than 5 years and are considered at low risk of recurrence by the investigator;
• Uncontrolled comorbidities including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;
• Herpes virus infection (except those with scab formation for more than 4 weeks);
• Respiratory viral infection (except those recovered for more than 4 weeks);
• Severe coronary artery disease or cerebrovascular disease, or other diseases deemed ineligible by the investigator;
• History of severe allergy to food, drugs, or vaccines, or potential allergy to immunotherapy as judged by the investigator.

• Age ≥ 18 years and ≤ 80 years;
• Voluntarily signed written informed consent;
• Agreed to provide tumor tissue and whole blood for sequencing; or able to supply raw gene sequencing data required for tumor neoantigen analysis and design of personalized anti-tumor neoantigen injection, including whole-exome sequencing data of tumor tissue, transcriptome sequencing data, and whole-exome sequencing data of peripheral blood;
• Patients with pathologically confirmed, clinically diagnosed Stage III resectable colorectal cancer or non-small cell lung cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Underwent radical resection of lesions;
• Received postoperative adjuvant therapy in accordance with standard guideline-recommended regimens, completed the full guideline-recommended treatment cycles, and no new lesions were detected on imaging examinations;
• Complete imaging records must be available within 1 week prior to initiation of personalized immunotherapy, including but not limited to whole-body PET-CT and brain MRI. If whole-body PET-CT is not feasible, chest CT, contrast-enhanced abdominal CT, or bone ECT is required;
• Adequate organ and bone marrow function:
  • White blood cell count ≥ 3,500/mcL
  • Absolute lymphocyte count \> 800/mcL
  • Absolute neutrophil count \> 1,500/mcL
  • Platelet count \> 100,000/mcL
  • Hemoglobin \> 10.0 g/dL
  • Total serum bilirubin \< 1.5 × upper limit of normal (ULN)
  • AST/ALT \< 2.0 × ULN
  • Serum creatinine \< 1.5 × ULN
• For pregnant or lactating women: female subjects of childbearing potential must have a negative pregnancy test within 7 days before enrollment, have no childbearing plan in the near term, and be willing to use effective contraceptive measures (contraception or other birth control methods) before and during the study;
• Male patients willing to use appropriate contraceptive measures;
• Able to comply with the study protocol and follow-up procedures.