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The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
Sponsor: Fudan University
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.
Official title: A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2022-12-12
Completion Date
2025-05-01
Last Updated
2025-01-15
Healthy Volunteers
No
Conditions
Interventions
PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Short-course radiotherapy
Shor-course radiotherapy: 25Gy/5Fx
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China