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Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
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.
Official title: Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-01-01
Completion Date
2028-12-31
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
PD-1 antibody (Toripalimab)
PD-1 antibody: (Toripalimab): 240mg q3w
Capecitabine
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
Oxaliplatin
130 mg/m² q3w
Irinotecan
200 mg/m² q3w
Radiation
45-50Gy/25Fx or 30Gy/15Fx
surgery
The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.
Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China