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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
PD-1 antibody: (Toripalimab): 240mg q3w
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
130 mg/m² q3w
200 mg/m² q3w
45-50Gy/25Fx or 30Gy/15Fx
The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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.
Time frame: up to 1 year
R0 resection rate
Complete resection rate, defined as no residual tumor cells at the surgical margin under the microscope or the naked eye.
Time frame: up to 1 year
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.
Time frame: up to 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.
Time frame: up to 3 years
Pathological tumor regression grading
Classify according to the Mandard tumor regression grading system.
Time frame: up to 1 year
Operation complications
intraoperative complications
Time frame: up to 1 year
Incidence of major surgical complications
From the date of surgery to 3 months after surgery, according to Clavien-Dindo classification score.
Time frame: up to 3 months
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