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MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
Sponsor: Fudan University
Summary
NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.
Official title: A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-08-13
Completion Date
2027-02-12
Last Updated
2025-02-21
Healthy Volunteers
No
Conditions
Interventions
PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 bid d1-14 q3w
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China