The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons .
The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.
Patient is 18-75 years old at the time of signing the informed consent form.
ECOG performance status 0-1.
Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
No distant metastasis lesions outside the pelvic.
Neutrophil < 1.5×10^9/L, PLT < 75×10^9/L.
TBIL > 1.5 ULN.
AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
Cr > 1.5 ULN.