Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer
Primary objectives:
Pathological complete response (pCR) rate;
Secondary objectives:
Treatment-related adverse events (CTCAE 5.0), clinical complete response (cCR) rate, major pathological response (MPR) rate, R0 resection rate, sphincter preservation rate, surgical complications, 3-year disease-free survival (DFS), and overall survival (OS);
1) Sign written informed consent before implementing any trial related processes;
2) Male or female, age ≥ 18 years;
3) ECOG score 0-1;
4) The primary lesion is a locally advanced rectal adenocarcinoma with histopathologically confirmed MSI-H/dMMR characteristics.;
1) Diagnose distant metastasis through CT/MR/EUS;
2) Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
3) Severe intestinal obstruction;
4) Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
Single group
Cindilimab、IBI310、Capecitabine、Oxaliplatin
DrugA. Neoadjuvant treatment phase The total treatment duration was 6 weeks PD-1：200mg IV, D1, Q3W IBI310：1.0mg/kg IV, D1,Q3W Capecitabine: 1000 mg/m2, Po, bid, d1-d14, q3w Oxaliplatin: 130 mg/m2, IV, D1, q3w B. Surgical treatment stage All patients underwent preoperative evaluation within 4-6 weeks after the end of neoadjuvant therapy, * CCR: waiting for observation follow-up; * yct0-2n0m0: local resection follow-up; * yct3-4a or n+:tme- follow-up.
Pathological complete response (PCR) rate
The proportion of subjects with no residual viable tumor cells and negative lymph nodes in the total subjects
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