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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
50Gy/25Fx
25Gy/5Fx
1000mg/m2 bid d1-14
300mg d1,q3w
200mg, bid
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGAnyang Tumor Hospital
Anyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGYunnan Cancer Hospital
Kunming, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGCR (Complete Response)
Complete response (CR) in malignant tumor patients is defined as the complete disappearance of all target lesions, normalization of tumor marker levels, and absence of new lesions for ≥4 weeks after treatment.
Time frame: 3 years
sphincter preservation rate
Time frame: 3 years
Grade 3 or higher toxicity rate
Time frame: 3 years
3yPFS (Progression-Free Survival)
PFS (Progression-Free Survival) in oncology is defined as the time from the initiation of treatment to the occurrence of disease progression or death from any cause , whichever occurs first.
Time frame: 3 years
3yLRFS (Local Recurrence-Free Survival)
LRFS (Local Recurrence-Free Survival) is a clinical endpoint in oncology that measures the time from treatment initiation to the occurrence of local recurrence or death from any cause , whichever occurs first, commonly used to assess tumor control efficacy after surgery or radiotherapy.
Time frame: 3 years
3yOS (Overall Survival)
Measures the time until death , regardless of cause, reflecting the ultimate therapeutic outcome .
Time frame: 3 years
Surgical complications
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.