Table 1.

Schema of single-arm clinical trial

Item	Screening period		Treatment period			Perioperative period	End of trial	Survival follow-up
	−28 to 0 days	−7 to 0 days	4 weeks after the first treatment session	7 weeks after the first treatment session	n cycles		30 days after checkout
Window period (days)	——	——					±7
Informed consent	×
Demographics Medical history History of tumour treatment	×
Physical examination		×	×	Every 3 weeks		×	×
Vital signs		×	×	Every 3 weeks		×	×
ECOG		×	×	Every 3 weeks ×			×
Pregnancy test		×					×
Infection screening	×						×
Imaging	×		×	Every 6 weeks			×	×
Tumour markers		×	×	Every 6 weeks			×
Echocardiography	×						×
Tumour tissue	×
12-lead ECG		×	When clinically indicated				×
Blood biochemistry		×	×	Every 3 weeks			×
Routine blood test		×	×	Every 3 weeks			×
Routine urine test		×	×	Every 3 weeks			×
Routine stool test		×	×	Every 3 weeks			×
Thyroid function, pituitary function, coagulation		×	×	Every 3 weeks			×
Gut microbiome testing for the stool sample		×		×			×
Biomarker testing for the blood sample		×		×			×
Surgical resection						×
Surgical complications						×
Concomitant medication	×	×	×	Every 3 weeks			×
Adverse events	×	×	×	Every 3 weeks			×
Compliance evaluation	×	×	×	Every 3 weeks
Dispensing of drugs			×	Every 3 weeks
Recovery of drugs			×	Every 3 weeks			×
Follow-up on survival status and antitumour treatment								×