Efficacy and safety of warming Yang and dredging intestines method in metastatic colon cancer maintenance

Table 1 Screening, intervention, evaluation schedule

Item	Before treatment (within 2 weeks)	Each treatment cycle	End of treatment or withdrawal
Collection of basic information
Admission screening form	×	-	-
Signing the informed consent form	×	-	-
Baseline information	×	-	-
Effectiveness index
CT/MRI1	×	Every 2 months or at a time point deemed appropriate by the investigator	×
Tumor marker2	×	×	×
Safety indicator
Blood pressure	×	×	-
Blood routine	×	×	-
Blood coagulation function	×	×	-
Thyroid gland function	×	Every 2 months or at a time point deemed appropriate by the investigator	-
24-hour urinary protein quantification	×	Every 2 months or at a time point deemed appropriate by the investigator	-
Liver and kidney function	×	×	-
ECG	×	×	-
Echocardiogram	×	×	-
Urinalysis	×	×	-
Stool routine + occult blood	×	×	-
Recording adverse events	-	×	×

¹Computed tomography or magnetic resonance imaging of the head, chest, abdomen, and pelvis and additional examination can be performed based on actual condition of the patients.

²Required items for serum tumor indicator test are carcinoembryonic antigen and carbohydrate antigen (CA) 19-9; optional items are CA125, CA153, CA724, and CA242.

All study activities can only be performed following signed informed consent. ×: Required fields to be filled in; CT: Computed tomography; MRI: Magnetic resonance imaging; ECG: Electrocardiogram.