The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer. The main questions it aims to answer are: To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX(Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO)regimen. Two CAOPX regimens were treated one week apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
375
Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGCR
complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients
Time frame: pCR :within 10 days after surgery;cCR :13 weeks after radiotherapy begins
AE rate
Adverse event rate
Time frame: during treatment
NAR score
Neoadjuvant rectal(NAR)score:It is based on the scoring criteria of preoperative treatment
Time frame: within 10 days after surgery
ORR
objective response rate objective response rate objective response rate objective response rate
Time frame: within 10 days after surgery
OPR
organ preservation rate organ preservation rate organ preservation rate
Time frame: immediately after surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with tislelizumab
Time frame: up to 3 weeks after using tislelizumab
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