A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Disease free time
研究概览
简要总结
The purpose of this study is to explore whether adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of pancreatic cancer. At the same time, this study will evaluate the successful establishment rate of organoid from fresh surgical specimens , and explore the concordance between drug sensitivity test results and patients' treatment response.
详细描述
The poor prognosis of pancreatic cancer is not just because of the high malignancy of the tumor itself, but also its poor response to chemotherapy. At present, patient's drug-sensitivity is assessed by progression time after treatment. Therefore, it is difficult to judge a patient's sensitivity to a drug before adjuvant chemotherapy. Organoid is a new tumor model, which has the potential to test the drug sensitivity before chemotherapy.
Our center's previous experience has shown that the success rate of pancreatic cancer organoid culture is 77.6%. The previous research has confirmed that pancreatic cancer organoid was highly consistent with the original tissue in terms of genomics and histomorphology. More importantly, the investigators have tested the five first-line drug-sensitivity in 39 pancreatic cancer organoids, and compared the test results with the clinical treatment response of these patients, confirming that organoid can accurately evaluate the chemotherapy drug-sensitivity.
This is a single-center, prospective, open-label, randomized, controlled clinical trial, designed to explore whether adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve outcomes in pancreatic cancer patients. At the same time, the consistency between the drug sensitivity test results and the treatment response of patients will be analyzed. Also, the radiosensitivity of organoid will be tested, and be compared with the patients' response to radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old and ≤80 years old.
- •Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.
- •Histology confirmed pancreatic adenocarcinoma.
- •Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
- •No metastases are found in preoperative examination.
- •No prior chemotherapy or radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of greater than 90 days, as judged by the investigator.
- •Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm
- •Normal liver function: serum total bilirubin≤2.0mg/dl, aminotransferase (ALT) and aspertate aminotransferase (AST) <2.5 times of the upper limit of normal value.
- •Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min.
- •The pancreatic cancer organoid were cultured successfully.
- •No severe comorbidities.
排除标准
- •Patients with poor condition can not tolerate chemotherapy and targeted therapy.
- •Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
- •Patients diagnosed with other cancer within 5 years.
- •Patients who are pregnant or breastfeeding.
- •Patients enrolled in other clinical trials or incompliant of regular follow up.
- •Patients who did not provide an informed consent.
结局指标
主要结局
Disease free time
时间窗: 1-2 years
Time from the date of randomization to recurrence based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier.
次要结局
- Overall survival time(2-4 years)
- The successful establishment rate of organoids(2-4 years)
- 1-year disease-free survival(1 year)
- Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics).(2-4 years)
- Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics).(2-4 years)
研究者
Guo ShiWei
Associated Professor at the Institute of Pancreatic Surgery
Changhai Hospital