Clinical Trial

Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

Study acronym: TNTIT
Recruiting Phase 1/2
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Summary
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).
Trial Details
NCT Number NCT07561060
Lead Sponsor Fudan University
Conditions Rectal Cancer
Enrollment 50 participants
Start Date 2024-01-01
Primary Completion 2027-12 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-01