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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
PD-1 antibody (Toripalimab): 240mg d1 q3w
Oxaliplatin: 130mg/m2 d1 q3w
Capecitabine: 1000mg/m2 bid d1-14 q3w
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPathological complete response (pCR) rate
Rate of pathologic complete response (pCR) after surgery
Time frame: 1 month after the surgery
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Time frame: From the date of randomization until 3 months after the completion neoadjuvant therapy
Anal function
Anal function will be evaluated using LARS score
Time frame: From the date of randomization until 36 months after the surgery
Surgical complication
Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Time frame: The surgical complications were assessed within 3 months after the surgery
3-year local recurrence free survival (LRFS) rate
Rate of 3-year local recurrence free survival
Time frame: From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months
3-year disease free survival (DFS) rate
Rate of 3-year disease free survival
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
3-year overall survival (OS) rate
Rate of 3-year overall survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 36 months
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