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.
Single group
PD-1 antibody (Toripalimab)
DrugPD-1 antibody: (Toripalimab): 240mg q3w
Capecitabine
DrugCapecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
Oxaliplatin
Drug130 mg/m² q3w
Irinotecan
Drug200 mg/m² q3w
Radiation
Radiation45-50Gy/25Fx or 30Gy/15Fx
surgery
Procedure/SurgeryThe type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.
Pathological complete response rate
Defined as pathological evaluation of resected tumor tissue and regional lymph nodes, with no residual tumor cells, complete disappearance of all tumor lesions, and no appearance of new lesions.
R0 resection rate
Complete resection rate, defined as no residual tumor cells at the surgical margin under the microscope or the naked eye.
3-year Progression-Free Survival
Defined as the time from the date of start treatment until the date of local recurrence or local recurrence progression or distant metastases or death from any cause or censored at last follow-up within 3 years.
Overall Survival
Defined as the time from the date of start treatment until the date of death from any cause or censored at last follow-up.
Pathological tumor regression grading
Classify according to the Mandard tumor regression grading system.
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