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TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor

2017年8月11日 更新者:BGI, China

Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor

The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.

研究概览

详细说明

20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.

研究类型

介入性

注册 (预期的)

20

阶段

  • 不适用

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。

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 75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:

  1. Be ≥18 and ≤75,no gender based;
  2. Expression of HLA-A0201/1101/2402;
  3. Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;
  4. Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;
  5. Failure in conventional treatment, or though benefit from chemotherapy the patient can't tolerant subjectively;
  6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 and an anticipate life expectancy of at least three months,be cooperate to adverse reactions monitoring and therapeutic evaluation of the treatment;
  7. Participants of child-bearing potential must agree to use adequate contraceptive methods up to 12 months after the pretreatment;
  8. Serology:Seronegative for HIV antibody,seronegative for hepatitis C antibody. Hematology:Absolute neutrophil count ≥ 1000/mm(3) without the support of filgrastim ,WBC ≥ 3000/mm(3),lymphocyte count ≥ 800/mm(3),Platelet count ≥ 100,000/mm(3),Hemoglobin ≥ 9.0 g/dl Chemistry:Serum ALT/AST ≤ 2.5 times the upper limit of normal,Serum Creatinine ≤1.6 mg/dl,Total bilirubin < 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin < 3.0 mg/dl;
  9. Patients or their legal representatives are willing and able to understand and written informed consent form for the trial;

Exclusion Criteria:

  1. Is pregnant or breastfeeding,or expecting to conceive;
  2. Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
  3. Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.
  4. Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);
  5. Have clinical symptoms of central nervous system metastases;
  6. Have used a large number of glucocorticoids or other immunosuppressive agents within 4 weeks;
  7. Have any active autoimmune disease ;
  8. Be in active infection or undergo an unknown cause fever> 38.5 ℃ during screening or before the first administration(except tumor fever which evaluated by the researchers have no effect to enrollment );
  9. Received chemotherapy or small molecule targeted drug therapy in 4 weeks prior to chemotherapy pretreatment;
  10. Received any antibody drug therapy (including PD-1 and CTLA-4) within 6 weeks before the treatment period;
  11. Severe liver and kidney dysfunction or uncontrollable diabetes, hypertension and other chronic systemic diseases; severe coagulation disorders, mental illness, cardiopulmonary disease,hydrothorax or ascites;

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:不适用
  • 介入模型:单组作业
  • 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:Experimental

Drug:Cyclophosphamide

Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells

Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1,3,5,11,17,23,35,47.
其他名称:
  • TSA-DC vaccine
300 mg/m2 by vein before the first cell infusion.
其他名称:
  • 胞毒素

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
safety endpoint
大体时间:one year
All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.
one year
Overall Response Rate
大体时间:one year
Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.
one year
Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.
大体时间:one year
one year

次要结果测量

结果测量
措施说明
大体时间
Secondary safety endpoint
大体时间:one year
All local or systemic reactions, adverse events and serious adverse events that occurred from entering the trial until 30 days after the last treatment;
one year
Six month DCR(CRR+PRR+SDR)
大体时间:6 month
Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;
6 month
Duration of Response(DOR)
大体时间:one year
The time from the first tumor evaluation of remission(CR + PR ) till the first assessment of PD or the end the study.
one year
Progression-free survival(PFS)
大体时间:one year
The time from entering the trial till the subject has been diagnosed with progression of disease or died.
one year
rate of 12-month survival
大体时间:one year
Percentage of cases with 12 months survival after initiation of treatment in all the subjects;
one year
Quality score of life improvement
大体时间:one year
Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods.
one year

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。

赞助

调查人员

  • 首席研究员:ZengQing Guo, Professor、Fujian Cancer Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (预期的)

2017年12月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2019年6月1日

研究注册日期

首次提交

2017年6月11日

首先提交符合 QC 标准的

2017年6月12日

首次发布 (实际的)

2017年6月14日

研究记录更新

最后更新发布 (实际的)

2017年8月14日

上次提交的符合 QC 标准的更新

2017年8月11日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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