OncoMatch/Clinical Trials/NCT07154316
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Is NCT07154316 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CAPOX and PD-1 for colorectal cancer.
Treatment: CAPOX · PD-1 · Celecoxib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Prior therapy
Cannot have received: chemotherapy
No prior chemotherapy or any other anticancer therapy before enrollment
Cannot have received: immunotherapy
No prior immunotherapy
Lab requirements
Blood counts
hemoglobin ≥90 g/L; ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L; serum albumin ≥30 g/L
Kidney function
serum creatinine <1×ULN
Liver function
ALT and AST ≤2.5× ULN; ALP ≤2.5×ULN; serum total bilirubin <1.5×ULN
Cardiac function
No clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of NYHA class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months
Baseline blood routine and biochemical parameters not meeting the following criteria: hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelets ≥100×10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); alkaline phosphatase (ALP) ≤2.5×ULN; serum total bilirubin <1.5×ULN; serum creatinine <1×ULN; serum albumin ≥30 g/L. Clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of NYHA class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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