Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1-Year Survival Rates
研究概览
简要总结
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
详细描述
There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer
- •Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
- •Have not received gemcitabine-based regimen after surgery
- •No systemic treatment after diagnosis of recurrence
- •ECOG score 0-1
- •Expected survival ≥ 3 months;
- •Liver function is essentially normal: absolute neutrophil count > 1500/mm ³; platelet count > 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) > 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal
- •Appropriate to participate in this trial as assessed by the investigator before entering the study
- •Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
- •Signed Informed Consent Form
排除标准
- •Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue
- •Received gemcitabine-based regimen after surgery
- •Systemic treatment after diagnosis of recurrence
- •Patients with previous allergic reactions to similar drugs
- •Pregnant or lactating patients
- •Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening)
- •History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
- •Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc
- •Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc)
- •Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment
- •Patients with other previous malignancies who are not cured
- •Immunodeficient patients, such as HIV-positive
- •Uncontrollable psychosis
研究组 & 干预措施
Tislelizumab combined with Nab-paclitaxel and Gemcitabine
干预措施: Tislelizumab (Drug)
Tislelizumab combined with Nab-paclitaxel and Gemcitabine
干预措施: Nab paclitaxel (Drug)
Tislelizumab combined with Nab-paclitaxel and Gemcitabine
干预措施: Gemcitabine (Drug)
Nab-paclitaxel and Gemcitabine
干预措施: Nab paclitaxel (Drug)
Nab-paclitaxel and Gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
1-Year Survival Rates
时间窗: Up to 2 years
The proportion of patients who survive more than 1 year after treatment.
次要结局
- Overall Response Rate（ORR)(Up to 2 years)
- Progression Free Survival (PFS)(Up to 2 years)
- Adverse Events (AEs)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
研究者
Guo ShiWei
Principal Investigator
Changhai Hospital