This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR/MSI-H) locally advanced colorectal cancer. All patients will receive three cycles of tislelizumab neoadjuvant therapy followed by curative surgery. Postoperatively, based on surgical pathology, patients will receive adjuvant therapy with a regimen selected by the investigator or adopt a watch-and-wait strategy. The investigators will conduct a 5-year prospective follow-up. The investigators plan to enroll approximately 30 subjects.
Study Type
OBSERVATIONAL
Enrollment
30
Pathological complete response
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab.
Time frame: Up to 3 weeks after surgery
Treatment emergent adverse events
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.
Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Clinical complete response
Time frame: Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 5 years
Treatment related adverse events
Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Immunotherapy related adverse events
Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
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