NCT07150949

Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Rectal Cancer
• Neoadjuvant Therapy

Interventions

Type	Name	Description
RADIATION	Long-course radiotherapy	Long-course radiation: 50Gy/25Fx
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2 d1 q3w
DRUG	Capecitabine	Xeloda
DRUG	Celecoxib	celecoxib 200 mg orally twice a day
RADIATION	Short-course radiotherapy	Short-course radiotherapy: 25Gy/5Fx
DRUG	Serplulimab	Serplulimab 300mg, d1, q3w

Timeline

• Start date: 2025-08-28
• Primary completion: 2027-08-31
• Completion: 2028-08-31
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: China