Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer
Nanfang Hospital, Southern Medical University
53 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
Summary
This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Toripalimab 240mg,d1,q3w
25Gy/5Fx
135mg/m2 d1 q3w
1200mg/m2 d1-14 q3w
Locations(1)
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NCT05877573