NCT03236883Unknown1 期
Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.
详细描述
Allogeneic hematopoietic stem cell transplantation has been successfully used for the treatment of hematopoietic malignancy. In recent years, non-myeloablative hematopoietic stem cell transplantation (NST) has been introduced to treat solid tumors due to the Graft-versus tumor effect. In this study, the investigators try to evaluate the safety and efficacy of NST in the treatment of unresectable pancreatic cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •PET-CT/EUS-FNA cytologically confirmed stage III -Ⅳ of pancreatic cancer
- •Between 18 and 80 years old
- •Karnofsky Performance Status (KPS) ≥ 70%，Guaranteed treatment for 3 months
- •Normal functions of heart, lung and kidney
- •Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3， start the treatment within 14 days after these results meet the requirements
- •A life expectancy > 3 months
- •Informed consent signed
- •HLA-haplotype-matched immediate family health donors who have been confirmed by laboratory HLA genotypes
- •Interval the last anti-tumor treatment for more than 3 months
排除标准
- •Highly allergic or people with severe allergies
- •Brain metastasis or Primary central nervous system malignancy
- •Suffer from clinical illnesses that affect clinical trials, including but not limited to： Uncontrollable diabetes；active infectious disease or uncontrollable infection; acute and chronic liver disease; confirmation of HIV infection; uncontrollable hypertension, symptomatic congestive heart-failure, unstable angina pectoris, and myocardial infarction, uncontrollable arrhythmia over the last 6 months.
- •Combined heart, lung, kidney and other vital organs dysfunction
- •A serious coagulation dysfunction, a clear history of other tumors
- •Pregnant and lactating women
- •Mental illness, affecting the compliance of clinical trials
- •The patient will participate in other trials within 10 days prior to the trial or While participating in other tests
- •Patients underwent weight loss by 10% and above within 6 weeks before the start of the trial
- •Neutrophils<500mm^3 or Platelet count<50,000/mm^3
- •Need to drive and manipulate the machine during the trial
- •Donor's Inclusion Criteria:
- •First-degree relatives of patients
- •Age<55 years old
- •Normal functions of heart, lung and kidney
- •Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3、WBC≥ 3000/mm^3， start collecting stem cells within 14 days after these results meet the requirements
- •Informed consent signed
- •Donor's exclusion Criteria:
- •Highly allergic or people with severe allergies
- •The person who have history of atherosclerosis, venous thrombosis or autoimmune disease
- •A serious coagulation dysfunction, a clear history of other tumors
- •Infectious disease or carriers
- •Pregnant and lactating women
- •Mental illness, affecting the compliance of clinical trials
- •WBC<4000/mm^3、PLT<70*10^9/L
研究组 & 干预措施
GEM plus GPBSC
Experimental
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg
干预措施: Gemcitabine (Drug)
GEM plus GPBSC
Experimental
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg
干预措施: GPBSC (Other)
Gemcitabine
Other
干预措施: Gemcitabine (Drug)
GPBSC
Other
干预措施: GPBSC (Other)
结局指标
主要结局
Survival
时间窗: 3 months
Survival will be measured at 3 months after transplant.
次要结局
- Progression free survival（PFS）(3 months)
- Overall survival (OS)(3 months)
- Response rate(3 months)
- Adverse Events(3 months)
- Karnofsky Performance Status（KPS）(3 months)
研究者
研究点 (1)
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