NCT06940388 Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.
| NCT ID | NCT06940388 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | brenner baruch |
| Condition | Locally Advanced Rectal Cancer (LARC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2029-08 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects with histologically confirmed primary (non-recurrent) LARC (tumor 12 cm or less from the anal verge, as assessed by rigid proctoscopy), stage T3-4 N0 or TX N+ according to base-line pelvic MRI and PET-CT. * Patients who are planned for TNT and are surgical candidates as determined by the treating physician. * No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer. * No prior radiotherapy to the pelvis, for any reason. * Able to provide the FFPE block or 10 unstained slides from the colonoscopy for confirmation of the diagnosis, CPS status and for investigational purposes. * Age 18 years or more. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< 2. * 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
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