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Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer (HST)

Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer

To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

30

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tianjin
      • Tianjin、Tianjin、中国、30000
        • 招聘中
        • Tianjin Medical University Cancer Institute and Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:GEM plus GPBSC
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg
Chemotherapy: Gemcitabine is administered Intravenous injection once a week,at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.
其他:Gemcitabine
Chemotherapy: Gemcitabine is administered Intravenous injection once a week,at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
其他:GPBSC
immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Survival
大体时间:3 months
Survival will be measured at 3 months after transplant.
3 months

次要结果测量

结果测量
大体时间
不良事件
大体时间:3个月
3个月
总生存期(OS)
大体时间:3个月
3个月
反应速度
大体时间:3个月
3个月
Progression free survival(PFS)
大体时间:3 months
3 months
Karnofsky Performance Status(KPS)
大体时间:3 months
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jihui Hao, MD, PHD、Tianjin Medical University Cancer Institute and Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月1日

初级完成 (预期的)

2019年4月1日

研究完成 (预期的)

2019年4月1日

研究注册日期

首次提交

2017年7月12日

首先提交符合 QC 标准的

2017年7月28日

首次发布 (实际的)

2017年8月2日

研究记录更新

最后更新发布 (实际的)

2017年8月2日

上次提交的符合 QC 标准的更新

2017年7月28日

最后验证

2017年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Gemcitabine的临床试验

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