Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER

This is a Phase II open-label trial of neoadjuvant immunochemotherapy with Atezolizumab and CAPOX followed by surgery and potentially adjuvant chemotherapy for patients with localized resectable pMMR adenocarcinoma of the colon with a target accrual of 28 patients. The investigators will explore if appropriately timed neoadjuvant CAPOX with anti-PD-L1 mAb (Atezolizumab) can be administered safely and feasibly, and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors. Patients will receive 4 cycles of

Trial Details

NCT ID
NCT05870800
Phase
PHASE2
Sponsor
Baylor College of Medicine
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Tecentriq 1200 MG in 20 ML Injection + Capecitabine 1000 mg/m2 + Oxaliplatin 130 mg/m2
  • Oxaliplatin injection 85mg/m2 + Leucovorin 400mg/m2 + 5-Fluorouracil 2400mg/m2
  • Oxaliplatin 130mg/m2 + Capecitabine 1000mg/m2
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Signed Informed Consent Form
  • Age ≥18 years at time of signing Informed Consent Form
  • Ability to comply with the study protocol
  • MSS or pMMR tumor determined by local CLIA-certified PCR or IHC testing respectively.

For full eligibility, visit ClinicalTrials.gov.

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