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

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 ID
NCT07561060
Phase
PHASE1 / PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Tislelizumab
  • Capecitabine
  • Oxaliplatin
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Able to provide written informed consent, understand and comply with the requirements and evaluation schedule
  • ≥18, ≤75 years old
  • Histologically confirmed rectal adenocarcinoma
  • immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS

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 →