Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
详细描述
Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age >= 18 years；
- •Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- •Pancreatic cancer confirmed by histology or cytology;
- •Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;
- •Hematological indexes: Neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9 / L
- •Biochemical indicators: Total bilirubin <= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 1.5 x ULN; Creatinine clearance rate >= 60ml / min.
- •Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test:
- •Signed informed consent;
- •Follow the protocol and follow-up procedures.
排除标准
- •Have received systematic anti-tumor treatment.
- •Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment).
- •Active bacterial or fungal infection (> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).
- •Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group.
- •Autoimmune diseases or immune defects who are treated with immunosuppressive drugs.
- •Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group.
- •Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected.
- •Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.
研究组 & 干预措施
Concurrent radiochemotherapy combined with immunotherapy
Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.
干预措施: Tislelizumab (Drug)
Concurrent radiochemotherapy combined with immunotherapy
Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.
干预措施: Gemcitabine (Drug)
Concurrent radiochemotherapy combined with immunotherapy
Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.
干预措施: Nab paclitaxel (Drug)
Concurrent radiochemotherapy combined with immunotherapy
Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.
干预措施: Hypofractionated radiotherapy with simultaneous integrated boost (Radiation)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 2 years
RECIST Version 1.1
次要结局
- Median Overall survival (mOS)(Up to 2 years)
- Median Progression Free Survival (mPFS)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Pathological grade of tumor tissue after neoadjuvant therapy(Up to 1 years)
- Adverse Events(Up to 2 years)
- R0 resection rate(Up to 1 years)
研究者
Du Juan
Clinical Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School