TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
PD-1 antibody (Toripalimab): 240mg d1 q3w
Capecitabine: 1000mg/m2 bid d1-14 q3w
Short-course radiotherapy: 25Gy/5Fx
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGComplete response (CR) rate
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
Time frame: 1 month after the surgery or the decision of W&W
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy
3 year organ or anal preservation rate
3 year organ or anal preservation rate
Time frame: From date of randomization until the resection of rectum or anus, assessed up to 36 months.
3 year disease free survival rate
Rate of 3 year disease free survival
Time frame: From 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 local recurrence free survival rate
Rate of 3 year local recurrence free survival
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
3 year distant metastasis free survival rate
Rate of 3 year distant metastasis free survival
Time frame: From date of randomization until the date of first documented distant metastasis, assessed up to 36 months.
3 year overall survival rate
Rate of 3 year overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.
Rate of surgical complications
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.