NCT07150949 Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
| NCT ID | NCT07150949 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2027-08-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years, gender not limited 2. Pathologically confirmed rectal adenocarcinoma 3. ≤10 cm from the anus 4. Baseline stage T3-4/N+ 5. No distant metastasis 6. MSI/MMR status MSS/pMMR 7. Karnofsky performance status score ≥70 8. No prior chemotherapy or other anti-cancer treatment prior to enrollment 9. No prior immunotherapy prior to enrollment 10. Ability to comply with the study protocol 11. Written informed consent Exclusion Criteria: 1. Pregnancy or breast-feeding women; 2. Known history of other malignancies within 5 years; 3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc; 4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy); 5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction; 6. Acute cardiac infarction or cerebral ischemic stroke occurred within
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