This is a single arm, open-label, prospective phase II clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and immunotherapy (PD-1 antibody) for patients with locally advanced rectal cancer (LARC). A total of 40 patients 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 4 cycles of CAPOX chemotherapy. There are two cohorts according to the microsatellite instability status: (1) the micro-satellite stable (MSS) cohort(n=32), (2) the MSI-high cohort (n=8). 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
40
Sintilimab is a humanized IgG4 monoclonal antibody against the programmed death-1 (PD-1) receptor. Usage: 200mg ivgtt d1 q3w.
Usage: 1000mg/m2 d1-14 q3w
Usage: 130mg/m2 d1 q3w
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
pCR rate
Pathologic complete response rate
Time frame: The TME surgery will be recommended at 1 week after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
3-year DFS
3-year disease free survival rate
Time frame: Assessed up to 3 years
3-year local recurrence rate
3-year local recurrence rate
Time frame: Assessed up to 3 years
3-year OS
3-year overall survival rate
Time frame: Assessed up to 3 years
Grade 3-4 adverse effects rate
Radiotherapy, immunotherapy and chemotherapy related grade 3-4 adverse events rate
Time frame: Assessed up to 3 years
Surgical complications
Type and Rate of surgical complications
Time frame: Assessed up to 3 years from the TME surgery
Quality of Life Scale
The Quality of Life Scale (QoLS, range 0-60) will be used to evaluate the quality of life. Higher scores mean the better quality of life
Time frame: Assessed up to 5 years
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