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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Toripalimab 240mg,d1,q3w
25Gy/5Fx
135mg/m2 d1 q3w
1200mg/m2 d1-14 q3w
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGpCR rate
Pathologic complete response rate
Time frame: The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
3-year ORR
3-year objective response rate
Time frame: Assessed up to 3 years
3-year DCR
3-year disease control rate
Time frame: Assessed up to 3 years
3-year OS
3-year overall survival rate
Time frame: Assessed up to 3 years
AE
adverse event
Time frame: Assessed up to 3 years
SAE
Serious Adverse Event
Time frame: Assessed up to 3 years
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