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SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer
Sponsor: Fudan University
Summary
The study evaluates the combination of immunotherapy of PD-1/ CTLA4 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/ CTLA4 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: The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-09-01
Completion Date
2028-12-31
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Shor-course radiotherapy
Shor-course radiotherapy: 25Gy/5Fx
PD-1/CTLA4 Antibody
Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin
130mg/m2 d1 q3w
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China