At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years old
- ✓Pathologically confirmed adenocarcinoma
- ✓Clinical stage T1-3bN0 with tumor maximum diameter less than 4cm
- ✓Distance from anal verge less than 5 cm
- ✕Pregnancy or breast-feeding women
- ✕Pathologically confirmed signet ring cell carcinoma
- ✕Clinical stage T1N0 amenable to local resection
- ✕History of other malignancies within 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05555888Phase 2RecruitingUpdate OverdueUpdated 17mo ago · Completion was 27mo agoA Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating PD-1 antibody, Capecitabine, and 2 other interventions for Early Low Rectal Cancer. Currently recruiting, targeting 34 participants across 1 site.
Signals
Detailed Summary
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
Study Details
Timeline
Interventions
PD-1 antibody (Toripalimab): 240mg d1 q3w
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin: 130mg/m2 d1 q3w
Shor-course radiotherapy: 25Gy/5Fx