drugset / Trial / NCT07561060

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

NCT07561060

Phase 1/2 Recruiting 50 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2024-01-01
Primary completion
2027-12
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Background Capecitabine Small molecule 825 mg/m2 Oral
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications