Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+)
- Pathologically diagnosed as rectal adenocarcinoma
- Male or non-pregnant female
- Age: 18-70 years old
- Hematology examination：I. White blood cell count ≥4×10^9/L;II. Neutrophils ≥1.5×10^9/L;III. Platelet count ≥100×10^9/L;IV. Hemoglobin ≥9g/L
- Blood biochemical examination: total bilirubin, AST, ALT≤2.0×upper limit of normal; creatinine≤1.5×upper limit of normal
- Functional status: ECOG score 0-1 points or KPS score ≥70 points
- Obtain the patient's informed consent
Exclusion Criteria:
- Pathologically diagnosed as non-adenocarcinoma
- Age> 70 years old
- Patients with recurrence and distant metastasis
- Have a history of other malignancies
- Have had radiotherapy and/or chemotherapy
- Pregnant or breastfeeding women
- Mentally disordered
- Patients with severe heart, liver, and kidney damage
- Non-compliance or the investigator believes that the patient cannot complete the entire trial treatment