This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The organ preservation rate, tumor regression grade, long-term prognosis, and adverse effects will also be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
PD-1 antibody (Tislelizumab): 200mg d1 q3w
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin: 130mg/m2 d1 q3w
Sir Run Run Shao hospital
Hanzhou, Zhejiang, China
RECRUITINGPathological complete response (pCR) rate
The status of pCR will be evaluated after the TME surgery.
Time frame: within 10 days after surgery
Tumor regression grade
TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.
Time frame: within 10 days after surgery
Local recurrence rate(LRR)
Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.
Time frame: 3 years after sugery
Disease free survival(DFS)
The three-year disease-free survival of patients.
Time frame: 3 years after surgery
Overall survival(OS)
The three-year overall survival of patients.
Time frame: 3 years after surgery
Adverse effects rate
Rate of radiotherapy, chemotherapy and immunotherapy related adverse events
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rectal specific quality of life assessment via QLQ-CR29
Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the surgery
Quality of life assessment via QLQ-C30
Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the surgery
Validation of the Wexner score
The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.
Time frame: Months 3, 6, 12, 24, 36, 60 after the surgery
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