Table 1.
Intervention and assessment schedule for the INP trial
| Execute project | W-4–W0 | W1 | W2 | W3 | W4 | W5 | W6 | W8 | W10 | W12 | W20 | W24 | W36 | W48 |
| Screening period | ||||||||||||||
| Sequencing/neoantigen preparation | √ | |||||||||||||
| Neoantigen immunisation | √√ | √ | √ | √ | √ | √ | ||||||||
| Physical examination | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
| Laboratory examination | √* | √ | √ | √ | √ | √ | √ | √ | ||||||
| CT/MRI | √* | √ | √ | √ | √ | √ | ||||||||
| ctDNA detection | √* | √ | √ | √ | √ | √ | √ | |||||||
| IFN-γ, CD4 +T cells, CD8 +T cells | √* | √ | √ | √ | ||||||||||
| AEs (CTCAE) | √* | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
| QLQ (EORTC QLQ-C30) | √* | √ | √ | √ | √ | √ | ||||||||
| Survival follow-up | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
√√ Twice a week.
*Need to screen out qualified neoantigens before relevant testing.
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; ctDNA, circulating tumour DNA; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; INP, Individualized neoantigen tumor peptides.