The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.
Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.
Study Type
OBSERVATIONAL
Enrollment
50
7Gy/F, d7, q3w, 5 cycles
CAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m\^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m\^2 administered orally twice daily on day 1 to 14 of a 21-day cycle.
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGpathological complete response(pCR)
pCR is defined as no residual tumor in the surgical specimen.
Time frame: 1 year
3-year disease-free survival
the time from randomization to disease recurrence or patient death due to disease progression.
Time frame: 2 years
local recurrence rate
It's defined as disease-free proximal, distal and circumferential margins.And its progression was defined as an increase in tumor size.
Time frame: 3 years
overall survival(OS)
It's defined as the time after the first dose of study therapy to death from any cause.
Time frame: 5 years
Sphincter-sparing surgery rate
sphincter-sparing surgery rate
Time frame: 1 year
R0 Resection Rate(R0-R)
It's defined as the percentage of patients undergoing resection, defined as a tumour-free resection margin.
Time frame: 1 year
predictive biomarkers andquality of life(QoL)
Objective condition index include subjective perception index objective condition index and subjective perception index.
Time frame: 3 years
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