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SERRAC: Neoadjuvant Therapy for Rectal Cancer
NCT07150949Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2025
- Primary completion
- Aug 2027
- Countries
- 1
- Sponsor
- Fudan University
- Modality
- Small Molecules, Immune Checkpoint Inhibitors
- Conditions
- rectal cancer
01
Overview
Phase 2, randomised, open-label trial of serplulimab and celecoxib oral solution in rectal cancer (2 arms), sponsored by Fudan University. Primary endpoint: Complete Response Rate. Started Aug 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
LCRT + CAPOX
Long-course Radiotherapy (50Gy/25Fx) followed by 3 cycles of CAPOX
SCRT + CAPOX + Serplulimab + Celecoxib
Short-course Radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX + Serplulimab + Celecoxib
03
Who it enrols
Patients with pathologically confirmed rectal adenocarcinoma, T3-4/N+, M0, distance from anal verge ≤10cm, and MSS/pMMR status.
04
Endpoints
Primary
Complete Response Rate
Secondary
Grade 3-4 Acute Adverse Effects Rate
Anal Preservation Rate
Disease Free Survival
Local Recurrence Free Survival
Overall Survival
Rate of Surgical Complications
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