Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.

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 CPI

Trial Details

NCT ID
NCT06940388
Phase
PHASE2
Sponsor
brenner baruch
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Tislelizumab
  • Total neoadjuvant therapy (TNT)
Locations (sample)
  • Mainz, Germany|49.98185,8.28008
  • Petah Tikva, Israel|32.0888,34.88666

Key Eligibility Criteria

  • Subjects with histologically confirmed primary (non-recurrent) LARC (tumor 12 cm or less from the anal verge, as assessed by rigid proctoscopy), st…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →