The purpose of this study is to evaluate the efficacy and safety of short-course radiotherapy followed by ivonescimab and chemotherapy in participants with pMMR/MSS locally advanced rectal cancer. Patients were randomly assigned to experimental group A or control group B according to a 1:1 ratio. In group A, patients will receive neoadjuvant short-course radiotherapy followed by ivonescimab and chemotherapy. In group B, patients will receive neoadjuvant short-course radiotherapy followed by chemotherapy. After neoadjuvant treatment, the patients and investigator could choose one of the following treatments:(1) Surgery. The patients will receive surgery within 4-8 weeks after the last dose of capecitabine, and the surgical method is selected by the investigator, (2) Watch and Wait (only for patients with clinical complete response after neoadjuvant therapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
lvonescimab, DS1, D1,q3w, intravenous infusion
Oxaliplatin 130 mg / m2, D1, intravenous infusion, q3w, Capecitabine 1000 mg / m2,twice a day, oral,1-14 days, then rest for 7 days, q3w.
5\* 5Gy, once a day, 5Gy each time, for 5 days
The surgical method is selected by the investigator. Watch and Wait (only for patients with clinical complete response after neoadjuvant therapy)
Adverse events
Adverse events and surgical safety
Time frame: Through study completion, an average of 6 month
Complete response rate
The proportion of CR cases (pCR for those who underwent surgery and cCR for those who didn't receive surgery)
Time frame: 4 weeks after curative surgery for pCR; 2-4 weeks after the completion of neoadjuvant therapy (last dose of capecitabine) for cCR
Clinical complete response rate
The proportion of clinical complete response cases.
Time frame: 2-4 weeks after the completion of neoadjuvant therapy (last dose of capecitabine)
Pathologic complete response
The proportion of pathologic complete response cases for those who underwent surgery
Time frame: 4 weeks after surgery
TRG
Tumor regression grade according to AJCC TRG grading system
Time frame: 4 weeks after surgery
R0 resection rate
R0 resection rate
Time frame: 4 weeks after surgery
Local recurrence
Local recurrence
Time frame: 3 years after Randomization
Distant metastasis
Distant metastasis
Time frame: 3 years after Randomization
OS
Overall survial
Time frame: 3 years after Randomization
EFS
Event free of survival
Time frame: 3 years after Randomization
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