Radiation Oncology, Rectal Cancer
Conditions
Keywords
chemotherapy, tislelizumab, split-course hypofraction radiotherapy, locally advanced rectal cancer
Brief summary
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.
Detailed 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.
Interventions
RADIATIONsplit-course HFRT
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.
DRUGTislelizumab
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.
Sponsors
Fujian Medical University Union Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response(pCR) | 1 year | pCR is defined as no residual tumor in the surgical specimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence rate | 3 years | It's defined as disease-free proximal, distal and circumferential margins.And its progression was defined as an increase in tumor size. |
| overall survival(OS) | 5 years | It's defined as the time after the first dose of study therapy to death from any cause. |
| 3-year disease-free survival | 2 years | the time from randomization to disease recurrence or patient death due to disease progression. |
| R0 Resection Rate(R0-R) | 1 year | It's defined as the percentage of patients undergoing resection, defined as a tumour-free resection margin. |
| predictive biomarkers andquality of life(QoL) | 3 years | Objective condition index include subjective perception index objective condition index and subjective perception index. |
| Sphincter-sparing surgery rate | 1 year | sphincter-sparing surgery rate |
Countries
China
Contacts
Primary ContactBenhua Xu
Backup ContactMengxia Zhang
Outcome results
None listed