A Single-center, Observational, Prospective Cohort Study of ctDNA Testing in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer
研究概览
简要总结
The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.
详细描述
Pancreatic cancer is highly malignant with poor prognosis, and the overall 5-year survival rate is only about 9%. The value of neoadjuvant therapy in pancreatic cancer has been demonstrated by many studies, and a scientific and accurate evaluation of the efficacy of neoadjuvant therapy is crucial to its implementation and achieving the best outcomes. Circulating tumor DNA (ctDNA) analysis provides a non-invasive way to repeatedly assess the genomic profile of tumor. With improvements in detection techniques providing higher levels of sensitivity, ctDNA analysis is rapidly being accepted as a reliable tool in oncology. The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.
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
- •Newly diagnosed patients with non-metastatic pancreatic cancer;
- •The pathological features were identified as pancreatic ductal carcinoma;
- •Patients with clinical risk factors including significantly elevated CA19-9 levels at diagnosis, large primary tumor volume, large regional lymph node diameter, significant weight loss, and extreme pain;
- •Patients accept neoadjuvant chemotherapy voluntarily with the regimen of modified FOLFIRINOX, and disease evaluation should be conducted every two courses, surgery should be performed without delay if resection criteria have been met, and at least two courses of chemotherapy should be completed;
- •Age ≥18 years old;
- •No other tumor treatment within 4 weeks prior to enrollment;
- •Complete clinical data, including basic information, pathological information, treatment information;
- •The subjects voluntarily join the study and sign the informed consent with good compliance, and cooperate with the acquisition of tissue samples and regular blood samples.
排除标准
- •Any other systemic antitumor therapy priorly;
- •Concomitant malignancies under treatment;
- •Patients with a history of allergy to relevant chemotherapy agents;
- •Failure to comply with the requirements of the visit plan;
- •Patients who may be absent from the visit period for 2 weeks or more during the treatment period;
- •The researchers determine that the subjects have other factors that could have caused the study to be discontinued.
结局指标
主要结局
Objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer
时间窗: Up to 24 months
Pre-treatment ctDNA detection and mutation characterization in blood are used to evaluate objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer.
次要结局
- Rate of adverse reactions(One week during therapy and 3 months thereafter up to 24 months.)
- The correlation between detection of blood ctDNA and mutation characteristics before treatment and the rate of adverse reactions(One week during therapy and 3 months thereafter up to 24 months.)
- The timeliness and accuracy of ctDNA with CA19-9 and medical imaging in the detection of disease recurrence(Up to 24 months.)
- The recurrence of pancreatic cancer(One week during therapy and 3 months thereafter up to 24 months.)
- The correlation between postoperative ctDNA in blood and clearance of ctDNA after adjuvant therapy and overall survival (OS) in patients with operable pancreatic cancer(One week during therapy and 3 months thereafter up to 48 months.)
- The mechanisms of drug resistance to neoadjuvant chemotherapy(One week during therapy and 3 months thereafter up to 24 months.)