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Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
Sponsor: Fudan University
Summary
SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Official title: A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2025-08-28
Completion Date
2028-08-31
Last Updated
2025-09-02
Healthy Volunteers
No
Interventions
Long-course radiotherapy
Long-course radiation: 50Gy/25Fx
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Capecitabine
Xeloda
Celecoxib
celecoxib 200 mg orally twice a day
Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx
Serplulimab
Serplulimab 300mg, d1, q3w
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China