Dendritic Cell-immunotherapy for Advanced Hepatocellular Carcinoma
A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma
研究概览
详细说明
Hepatocellular carcinoma (HCC) is a high malignant tumor with a rapidly progressive clinical course. Surgery is the first choice of the treatment. However, most HCC patients have numerous tumors upon diagnosis, which are not possible to be treated by surgical resection. Currently, several treatment options are applied to treat unresectable HCC, including transcartheter arterial chemoembolization (TACE), percutaneous ethanol injection, radiofrequency ablation, chemotherapy and radiotherapy. Nevertheless, the therapeutic results of these treatment modalities are unsatisfied.
TACE is frequently applied to treat the patients with unresectable HCCs in daily practice. Embolization blocks the arterial blood supply to the tumor and results in tumor necrosis. However, clinical benefits are limited, and the response rate is only 30% Dendritic cells (DC), the most potent antigen-presenting cells, serve as a cancer vaccine to conduct an antigen-specific anti-tumor therapy. Dendritic cell-based immunotherapy has been applied to treat advanced HCC in our previous study. The clinical results of this study verify the feasibility of DC-based immunotherapy for HCC. However, the results are still unsatisfied.
In this proposal, investigators are going to treatment the patients having unresectable HCCs with DC vaccination followed by TACE. DC vaccination can provoke antigen-specific immunity and induce memory T-cells. TACE following DC vaccination may further promote T-cell immunity to treat cancer. Therefore, the specific aims in this study are:
- To determine whether DC vaccination followed by TACE can treat HCC effectively in a clinical trial.
- To determine whether DC vaccination can provoke memory T cells and following TACE can further promote anti-HCC immunity.
The achievement of this clinical trial will help to establish a new strategy for the treatment of unresectable HCC.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
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Taoyuan、台湾、33357
- Chang-Gung Memorial Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: >80000/ul; anticipated survival > 3 months, measurable tumors.
Exclusion Criteria:
- HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;
学习计划
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 |
|---|---|
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实验性的:dendritic cell treatment
phase 2, one treatment arm
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autologous dendritic cell vaccination
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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 |
|---|---|---|
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Incidence of Treatment-Related Adverse Events
大体时间:up to 48 months.
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To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.
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up to 48 months.
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Objective Tumor Response
大体时间:From date of first treatment until the date of first documented progression, assessed up to 48 months.
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To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.
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From date of first treatment until the date of first documented progression, assessed up to 48 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival (OS)
大体时间:From date of first treatment to death from any cause, assessed up to 48 months.
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To examine the survival of the patients.
Overall survival is defined as the time from the date of first treatment to death from any cause.
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From date of first treatment to death from any cause, assessed up to 48 months.
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Enhancement of Immunity
大体时间:Baseline and at specified intervals up to 48 months.
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evaluate the enhancement of immunity after treatments by measuring quantitative T-cell proliferation via mixed lymphocyte reaction (MLR).
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Baseline and at specified intervals up to 48 months.
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合作者和调查者
调查人员
- 首席研究员:Wei-Chen Lee, MD、Chang Gung Memorial Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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