The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
the Fourth Hospital of Hebei Medical University
Shijiazhuang, China
CR rate
CR defined as patient achieving pCR and cCR.
Time frame: within 5 weeks
MPR rate
MPR defined as patients achieving a major pathological response after surgery.
Time frame: within 3 weeks after surgery
R0-resection rate
R0-resection defined as patients without tumor cell infiltration in the tissue 1mm from the resection margin
Time frame: within 3 weeks after surgery
Preservation rate of adjacent invaded organs
The involved organs were successfully preserved during the operation
Time frame: within 3 weeks after surgery
ORR
Defined as the percentage of complete response (CR) and partial response (PR) to tumor volume reduction according to RECIST v1.1 criteria
Time frame: within 5 weeks
3-year Event Free Survival
EFS defined as time from randomization to objectively observed tumor progression (local recurrence, new disease, or distant metastasis), development of a second malignancy, or death (death from any cause).
Time frame: 3 years
3-year OS
OS defined as time from randomization to death from any cause.
Time frame: 3 years
Incidence of adverse reactions
Occurrence of adverse reactions during therapy
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Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region
Elective nodal irradiation: Large pelvic field
TME surgery
Time frame: 1 year