The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
Fudan University
34 participants
Dec 12, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
PD-1 antibody (Toripalimab): 240mg d1 q3w
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin: 130mg/m2 d1 q3w
Shor-course radiotherapy: 25Gy/5Fx
Locations(1)
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NCT05555888