A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Related Adverse Events
研究概览
简要总结
The prognosis of advanced hepatocellular carcinoma is poor. In this study, the eligible patients will be treated by tumor antigen-pulsed autologous dendritic cells and followed by TACE. The end points are to see tumor response and patient survival.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: >80000/ul; anticipated survival > 3 months, measurable tumors.
排除标准
- •HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;
结局指标
主要结局
Incidence of Treatment-Related Adverse Events
时间窗: up to 48 months.
To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.
Objective Tumor Response
时间窗: From date of first treatment until the date of first documented progression, assessed up to 48 months.
To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.
次要结局
- Overall Survival (OS)(From date of first treatment to death from any cause, assessed up to 48 months.)
- Enhancement of Immunity(Baseline and at specified intervals up to 48 months.)
研究者
Wei-Chen Lee
prof. Department of General Surgery
Chang Gung Memorial Hospital