Comparison of Therapeutic Effect Between Combination of Anti-PD-1 Antibody With mFOLFIRINOX and mFOLFIRINOX Alone in Metastatic Pancreatic Cancer Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The prognosis of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with metastatic pancreatic cancer.
详细描述
Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- ••Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
- •Recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
- •Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
- •ECOG score 0 or
- •Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
- •ALT and AST are less than 2 x ULN.
- •Signed informed consent.
排除标准
- ••History of participation of other clinical trails within 4 weeks
- •History of autoimmune disease or other condition receiving glucocorticoid treatment
- •History of receiving chemotherapy within 2 weeks
- •History of radiotherapy and molecular target therapy within 2 weeks
- •History if active tuberculosis
- •History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
- •Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
- •Hematological precancerous diseases, such as myelodysplastic syndromes.
- •Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
- •Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
- •Preexisting neuropathy > 1 (NCI CTCAE).
- •Immune deficiency syndrome, such as active tuberculosis and HIV infection.
- •Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
- •Severe serious wounds, ulcers or fractures.
- •Clinical evaluation is unacceptable
研究组 & 干预措施
Chemotherapy group
Treatment with modified-FOLFIRINOX Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
干预措施: Chemotherapy (Drug)
Combination group
Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2, Anti-PD-1 antibody 200mg.
干预措施: Combination drug (Drug)
结局指标
主要结局
Overall survival
时间窗: Through the study peirod, for 3 years
The period from the first study treatment to any cause of death
次要结局
- Disease control rate(Through the study peirod, for 3 years)
- Progression-free survival(Through the study peirod, for 3 years)
- Resection rate(Through the study peirod, for 3 years)
- Objective response rate(Through the study peirod, for 3 years)
- Carbohydrate antigen 19-9(Through the study peirod, for 3 years)
- Adverse effects(Through the study peirod, for 3 years)
- EORTC QLQ - PAN26 score(Through the study peirod, for 3 years)
研究者
TingBo Liang
Proffessor
Zhejiang University