Radiotherapy-free neoadjuvant strategy using sintilimab plus XELOX in locally advanced rectal cancer: A single-arm phase II trial

Table 1 Baseline characteristics, mean ± SD/n (%)

Characteristic	All patients (n = 41)
Age (years)	61.29 ± 9.48
Gender
Male	30 (73.2)
Female	11 (26.8)
Before treatment BMI (kg/m2)	22.99 ± 3.05
Hypertension	14 (34.1)
Diabetes	5 (12.2)
Smoking	15 (36.6)
Drinking	9 (22.0)
Before treatment clinical T stage
cT2	2 (4.9)
cT3	26 (63.4)
cT4a	13 (31.7)
cT4b	0 (0)
Before treatment clinical N stage
cN0	2 (4.9)
cN1	14 (34.1)
cN2	25 (61.0)
Lateral lymph node ≥ 7 mm	0 (0)
Clinical disease stage before treatment
Stage II (cT3-4N0)	2 (4.9)
Stage III (cT1-4N1-2)	39 (95.1)
CRM
Threatened	8 (19.5)
Negative	33 (80.5)
EMVI
Positive	10 (24.4)
Negative	31 (75.6)
Maximum length of tumor involvement (cm)	4.82 ± 1.55
Less than 4	18 (43.9)
Not less than 4	23 (56.1)
Distance from anal verge (cm)	6.71 ± 3.13
Less than 5	17 (41.5)
Not less than 5	24 (58.5)
Anal canal involvement	0 (0)
Sphincter involvement	0 (0)
Initial CEA level (ng/mL)	7.59 ± 14.68
Less than 5	26 (63.4)
Not less than 5	15 (36.6)
Neutrophil/Lymphocyte ratio	2.57 ± 1.17
Less than 2.2	20 (48.8)
Not less than 2.2	21 (51.2)
Number of neoadjuvant treatments
2	20 (48.8)
3	17 (41.5)
4	4 (9.7)
Patients’ mismatch repair status
dMMR/MSI-H	0 (0)
pMMR/MSS	41 (100)

BMI: Body mass index; CRM: Circumferential resection margin; EMVI: Extramural vascular invasion; CEA: Carcinoembryonic antigen; MSI-H: Microsatellite instability-high; dMMR: Mismatch repair-deficient; pMMR: Mismatch repair-proficient; MSS: Microsatellite stable.