Actively Recruiting
Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
Led by Fudan University · Updated on 2025-09-02
138
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Pathologically confirmed rectal adenocarcinoma
- Tumor located 10 cm or less from the anus
- Baseline tumor stage T3-4 with lymph node involvement
- No distant metastasis present
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
- Karnofsky performance status score 70 or higher
- No prior chemotherapy or anti-cancer treatment before enrollment
- No prior immunotherapy before enrollment
- Ability to follow the study protocol
- Provided written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- History of other cancers within the past 5 years
- Previous anti-tumor treatments including radiotherapy, chemotherapy, immune checkpoint inhibitors, or T cell therapies
- Severe neurological or mental illnesses such as schizophrenia, dementia, or epilepsy
- Severe heart disease, kidney dysfunction, or liver dysfunction
- Heart attack or stroke within 6 months before joining the study
- Uncontrolled infections needing systemic treatment
- Active autoimmune diseases or immunodeficiency
- History of organ transplantation or ongoing use of immunosuppressive drugs
- Known HIV infection, active syphilis, or active tuberculosis
- Allergies to any components of the study treatments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Z
Zhen Zhang, M.D, PH.D
CONTACT
Y
Yajie Chen, PH.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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