Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer

The goal of this clinical trial is to compare the efficacy and safety of the combination of immune checkpoint inhibitors (ICIs) and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of locally advanced colorectal cancer. The main question aims to answer are: Question 1: Compare the pathological complete response rate between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Question 2: Compare the survival outcomes and safety between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Two groups of participants will receive different

Trial Details

NCT ID
NCT06154538
Phase
PHASE2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Immune checkpoint inhibitor
  • FOLFOX regimen
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Jinan, Shandong, China|36.66833,116.99722

Key Eligibility Criteria

  • Age 18 to 75, no gender restrictions;
  • Histologically or cytologically confirmed colorectal adenocarcinoma;
  • Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging);
  • Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing;

For full eligibility, visit ClinicalTrials.gov.

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