In this study, participants with locally advanced rectal cancer patients will be treated according to MMR/MSI status. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, dMMR or MSI-H patients will receive 4 cycles of neoadjuvant Pd1 antibody Sintilimab,followed by one of the following treatments: (1) surgery and adjuvant treatment, (2)another 4 cycles of sintilimab, followed by radical surgery or observation (only for cCR) . For Cohort B, pMMR/MSS/MSI-L patients will be randomized to receive neoadjuvant chemoradiotherapy ± four cycles of Pd1 antibody Sintilimab,followed by one of the following treatments: (1) curative surgery and four cycles of adjuvant chemotherapy;(2)four cycles of chemotherapy then observation (only cCR after neoadjuvant therapy)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
130mg/m2, d1 q3w, in Capeox regimen (100mg/m2 when used cocurrently with radiotherapy), intravenous infusion
1000mg/m2, bid, qd1-14, q3w, in Capeox regimen, oral administration
200mg, d1 q3w, intravenous infusion
neoadjuvant radiotherapy with 50Gy to GTV, 45Gy to CTV in 25 fractions.
total mesorectal excision after neoadjuvant treatment
Watch and wait for cCR patients after neoadjuvant treatment
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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: 6 weeks after curative surgery for pCR; 6 weeks after the completion of neoadjuvant therapy for cCR
Acute toxiticy according CTCAE5.0
Acute toxiticy according CTCAE5.0
Time frame: From start of treatment to 3 months after the adjuvant therapy or last dose of treatment
Tumor regresssion grade according to AJCC TRG grading system
Tumor regresssion grade according to AJCC TRG grading system
Time frame: 6 weeks after curative surgery
R0 resection rate
R0 resection rate
Time frame: 6 weeks after curative surgery
Local recurrence
Local recurrence
Time frame: 5 years after curative surgery
Distant metastasis
Distant metastasis
Time frame: 5 years after curative surgery
Tumor response
tumor volume reduction rate (TVRR) reaching 20% or above
Time frame: 6 weeks after first study treatment
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