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 (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Demographics
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.
Frequently asked questions
Is NCT07154316 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages