Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer

This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX（Capecitabine and Oxaliplatin）, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS（MicroSatellite Stable） locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)（Complete Remission） and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.

Trial Details

NCT ID
NCT07154316
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • LCRT
  • SCRT
  • CAPOX
  • PD-1
  • Celecoxib
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Anyang, Henan, China|36.096,114.38278
  • Jinan, Shandong, China|36.66833,116.99722
  • Kunming, China|25.03889,102.71833
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Age 18-75 years, regardless of gender.
  • Pathologically confirmed rectal adenocarcinoma.
  • Tumor located ≤10 cm from the anal verge.
  • Baseline stage T3-4 and/or N+ (locally advanced disease).

For full eligibility, visit ClinicalTrials.gov.

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