This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
200 mg IV on Day 1 of each 21-day cycle.
Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
Shanghai Zhongshan Hospital, Shanghai
Shanghai, Shanghai Municipality, China
RECRUITINGComplete Response rate (CR rate)
defined as the proportion of participants with clinical complete response(cCR) or near clinical complete response (ncCR) who achieved local resection confirmed pCR determined by the investigators after 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy.
Time frame: From first dose up to 12 months, approximately
1/2/3 year organ-preservation rate
defined as the proportion of participants who survived and did not underwent TME in 1/2/3 year (in the CR set and full analysis set respectively)
Time frame: From first dose of radiotherapy up to 36 months, approximately
1/2/3 year EFS rate
defined as the proportion of participants who did not develop local recurrence, distant metastasis, new invasive primary lesions of colorectal cancer, or death in 1/2/3 year (in the CR set, non-CR set and full analysis set respectively)
Time frame: From first dose of radiotherapy up to 36 months, approximately
1/2/3 year OS rate
defined as the proportion of participants who survived in 1/2/3 year (in the full analysis set)
Time frame: From first dose of radiotherapy up to 36 months, approximately
Percentage of Participants With Adverse Events
Percentage of Participants With adverse events (AEs) , immune-related adverse events(irAE) and serious adverse events (SAEs) per the National Cancer Institute CommonTerminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: From first dose of radiotherapy up to 36 months, approximately
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825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.