Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy Versus Nab-Paclitaxel and Gemcitabine Alone for Locally Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The study is a prospective and observational cohort study. The purpose is to to investigate the safety and efficacy of nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma (PDAC)
详细描述
We will prospectively collect 100 patients who receive nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy or nab-paclitaxel and gemcitabine alone. Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.
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
- •aged 18-75 years;
- •histologically or cytologically proven diagnosis of pancreatic adenocarcinoma;
- •treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the National Comprehensive Cancer Network definitions);
- •no distant metastasis as defined by CT or MRI of the chest, abdomen and pelvis;
- •at least 1 measurable lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
- •an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- •adequate hematological, liver, renal function:
- •absolute neutrophil count≥1500 cell/mm3;
- •platelet count≥100×109/L;
- •hemoglobin concentration >90 g/L;
- •albumin≥30 g/L ;
- •total bilirubin<1.5 times the upper limit of normal;
- •alanine aminotransferase and aspartate aminotransferase≤3 times the upper limit of normal;
- •serum creatinine concentration<1.5 times the upper limit of the normal range or less and creatinine clearance rate≥45 mL/min;
- •life expectancy of at least 3 months.
排除标准
- •with any other malignancy within the 5 years before enrolment;
- •with active infections (bacterial, viral, or fungal) requiring systematic treatment, with hepatitis B or C infection, or a history of HIV infection, or receiving immunosuppressive therapy;
- •with peripheral sensory neuropathy at a grade >1;
- •with a history of allergy or hypersensitivity to the study drugs;
- •pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.
研究组 & 干预措施
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy
Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8). Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy. Radiotherapy started after two cycles of chemotherapy. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
干预措施: Radiotherapy (Radiation)
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy
Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8). Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy. Radiotherapy started after two cycles of chemotherapy. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
干预措施: Nab-paclitaxel (Drug)
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy
Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8). Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy. Radiotherapy started after two cycles of chemotherapy. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
干预措施: Gemcitabine (Drug)
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy
Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8). Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy. Radiotherapy started after two cycles of chemotherapy. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
干预措施: Camrelizumab (Drug)
Nab-Paclitaxel+Gemcitabine
Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8).
干预措施: Nab-paclitaxel (Drug)
Nab-Paclitaxel+Gemcitabine
Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8).
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: two years
defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Overall survival
时间窗: two years
defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
次要结局
- Adverse events(two years)
- Tumor response(two years)
研究者
Ming Kuang
The vice president
Sun Yat-sen University