Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pathological complete response(pCR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HFRT with concurrent chemotherapy and immunotherapy
CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT
干预措施: split-course HFRT (Radiation)
HFRT with concurrent chemotherapy and immunotherapy
CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT
干预措施: CAPOX chemotherapy (Drug)
HFRT with concurrent chemotherapy and immunotherapy
CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT
干预措施: Tislelizumab (Drug)
结局指标
主要结局
pathological complete response(pCR)
时间窗: 1 year
pCR is defined as no residual tumor in the surgical specimen.
次要结局
- 3-year disease-free survival(2 years)
- local recurrence rate(3 years)
- overall survival(OS)(5 years)
- Sphincter-sparing surgery rate(1 year)
- R0 Resection Rate(R0-R)(1 year)
- predictive biomarkers andquality of life(QoL)(3 years)
研究者
Benhua Xu
Director
Fujian Medical University Union Hospital