At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
neoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle
neoadjuvant chemoradiation therapy
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, China
The rate of cCR
Rate of patients who achieve clinical complete response
Time frame: 2 years
The rate of organ preservation
Rate of patients who achieve organ preservation
Time frame: 2 years
The rate of anus preservation
Rate of patients who achieve anus preservation
Time frame: 2 years
pCR rate
Rate of pCR patients after surgery
Time frame: 2 years
Disease free survival(DFS)
DFS was defined as the duration from the date of randomization to the date of the first recurrence (local, distant, or mixed) or death.
Time frame: 2 years
overall survival(OS)
OS was calculated from the date of randomization.
Time frame: 2 years
Quality of life
The QoL was assessed by EORTC QOL Core Questionnaire.
Time frame: 2 years
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