This phase II/III trial studies how well neoadjuvant short-course radiotherapy and chemotherapy with or without PD-1 inhibitors works in treating patients with locally advanced rectal adenocarcinoma. Neoadjuvant short-course radiation therapy followed by two-drug regimen chemotherapy, such as CAPOX, were shown to be non-inferior to standard long-course chemoradiotherapy in our previous STELLAR study. Immune checkpoint inhibitors (ICIs) using monoclonal antibodies, such as PD-1 or PD-L1 inhibitor, show promising efficiency and reliable security in some limited sample prospective or retrospective studies. When treating patients with locally advanced rectal cancer, giving sequential neoadjuvant short-course radiotherapy and chemotherapy with PD-1 inhibitor may work better.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
588
PD-1 inhibitor
Pelvic radiation
chemotherapy regimen
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, China
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Shenzhen, China
complete remission
The rate of pathological complete remission plus clinical complete remission
Time frame: one year
Disease-free survival rate
Time frame: three year
Incidence of acute toxicities during radiation, chemotherapy ± immunotherapy
Time frame: three months
Incidence of surgical complications
Time frame: 30 days
Overall survival rate
Time frame: three year
Locoregional recurrence rate
Time frame: three year
Distance metastasis rate
Time frame: three year
Radical resection (R0)
Time frame: one year
Quality of life (QoL)
Quality of life will be evaluated using EORTC QLQ-C30 (range 0-100). It evaluates the quality of life from 30 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Quality of life (QoL)
Quality of life will be evaluated using EORTC QLQ-Cr29 (range 0-100). It evaluates the quality of life from 29 aspects, including defecation function, urine function,pain, sex function, etc. The higher scores mean a better quality of life.
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Quality of life (QoL)
Quality of life will be evaluated using Wexner score(range 0-20). It evaluates the defecation function. The lower scores mean a better quality of life.
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
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