A Prospective, Observational, Multicenter Study on Biomarkers for Predicting the Efficacy and Toxicities of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Based on Tissue and Plasma Exosome RNA
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- TRG
研究概览
简要总结
Backgrounds: A multicenter randomized phase III trial (NCT02605265) proved that adding irinotecan guided by UGT1A1 to capecitabine-based neoadjuvant chemoradiotherapy significantly increases complete tumor response. The treatment toxicities were increased but tolerable.
Purposes: This study aims to identify the predictive biomarkers (from patients' tumor biopsy samples and peripheral blood samples before neoadjuvant therapy) for predicting the response and toxicities to neoadjuvant therapy to stratify patients and optimize treatment strategy.
详细描述
OBJECTIVES:
Primary:
- Establish a predictive model for response based on tissue RNA and plasma exosome RNA
- Establish a predictive model for toxicities based on tissue RNA and plasma exosome RNA
Secondary:
- Internal validation of the established predictive models
- External validation of the established predictive models
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological confirmed adenocarcinoma
- •Clinical stage T3-4 andor N+
- •The distance from anal verge less than 12 cm
- •No suspicious metastatic disease (M1)
- •ECOG PS 0-1
- •UGT1A1*28 6/6 or 6/7
- •No previous anti-cancer therapy
排除标准
- •Pregnancy or breast-feeding women
- •Serious medical illness
- •Baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- •DPD deficiency
- •UGT1A1*28 7/7
研究组 & 干预措施
Good response
TRG of 0-1 is defined as good response.
干预措施: Radiation (Radiation)
Good response
TRG of 0-1 is defined as good response.
干预措施: Capecitabine-Irinotecan Combination (Drug)
Poor response
TRG of 2-3 is defined as poor response.
干预措施: Radiation (Radiation)
Poor response
TRG of 2-3 is defined as poor response.
干预措施: Capecitabine-Irinotecan Combination (Drug)
Light toxicity
No grade 3-4 toxicities occur during neoadjuvant therapy.
干预措施: Radiation (Radiation)
Light toxicity
No grade 3-4 toxicities occur during neoadjuvant therapy.
干预措施: Capecitabine-Irinotecan Combination (Drug)
Heavy toxicity
Grade 3-4 toxicities occur during neoadjuvant therapy.
干预措施: Radiation (Radiation)
Heavy toxicity
Grade 3-4 toxicities occur during neoadjuvant therapy.
干预措施: Capecitabine-Irinotecan Combination (Drug)
结局指标
主要结局
TRG
时间窗: Surgery scheduled 6-8 weeks after the end of neoadjuvant therapy
Tumor regression grade
Toxicities
时间窗: Up to 2 years
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
次要结局
- Local Control rate(3 years)
- Overall Survival(3 years)
- Progression-free Survival(3 years)
- pCR(Surgery scheduled 6-8 weeks after the end of neoadjuvant therapy)