OncoMatch/Clinical Trials/NCT06940388
Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.
Is NCT06940388 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and Total neoadjuvant therapy (TNT) for locally advanced rectal cancer (larc).
Treatment: Tislelizumab · Total neoadjuvant therapy (TNT) — This prospective, multi-center, phase II randomized controlled trial will evaluate the actual benefit of adding immunotherapy with tislelizumab to the currently most effective approach against LARC, namely TNT. In this trial, we will harness several elements that may each potentially contribute to an overall high efficacy, at least in local outcomes: nCRT rather than SCRT, full length (8 cycles of mFOLFOX6) of consolidation chemotherapy, CIMT following nCRT (exploiting the upregulation of the immune response induced by the latter) and tislelizumab (with its theoretical advantage over other CPIs). In line with the changing treatment paradigms in LARC, in which high therapeutic efficacy translates into the possibility to avoid TME, the trial will have a novel primary endpoint of long-term unmaintained cCR, i.e. 3 year TME-free survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3-4 N0, TX N+ (pelvic MRI and PET-CT)
stage T3-4 N0 or TX N+ according to base-line pelvic MRI and PET-CT
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer
Cannot have received: immunotherapy
No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer
Cannot have received: radiotherapy
No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer
Cannot have received: surgery
No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer
Cannot have received: radiotherapy
No prior radiotherapy to the pelvis, for any reason
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co- stimulation or checkpoint pathways
Lab requirements
Blood counts
WBC > 2000/µL; Neutrophils > 1500/µL; Platelets > 100 x 10^3/µL; Hemoglobin > 9.0 g/dL
Kidney function
Serum creatinine < 1.5 x ULN or calculated creatinine clearance > 60 mL/min (using the Cockcroft Gault formula)
Liver function
AST and ALT < 2.5 x ULN. Total bilirubin < 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)
Screening laboratory values must meet the following criteria (using CTCAEv5.0): i) WBC > 2000/µL ii) Neutrophils > 1500/ µL iii) Platelets > 100 x 103/ µL iv) Hemoglobin > 9.0 g/dL v) Serum creatinine < 1.5 x ULN or calculated creatinine clearance > 60 mL/min (using the Cockcroft Gault formula) vi) AST and ALT < 2.5 x ULN. vii) Total bilirubin < 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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