Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection - Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Hepatocellular carcinoma (HCC) is the most common primary liver tumor. Surgical resection remains the first choice for early-stage HCC because the result is superior to other treatments and not limited to liver donation. However, liver resection is criticized because the tumor recurrence rate is more than 50% in 5 years although the tumors are completely resected. In our large-scale study including 1639 patients with liver resection for HCC, the 1-, 3-, and 5-year disease-free survival were 73.7%, 58.3% and 53.3%, respectively. Currently, there are no effective treatments used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DCs) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DCs pulsed with tumor-associated antigens can be used to conduct tumor-specific immunotherapy. Thereafter, DCs pulsed with HCC tumor antigens may be used as an adjuvant therapy to prevent HCC recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients have curative liver resection for primary or recurrent HCCs which are diagnosed by pathological figures, and the risk nomogram scores of tumor recurrence are $\ge 101$ [Hepatitis, score 57; platelet $< 100\times10^3$, score 72; multiple tumors, score 69; cirrhosis, score 62; microvascular invasion, score 100; total tumor volume $> 43.3\text{cm}^3$, score 90].
- •Age ≧20 years old and sign informed consent.
- •BCLC stage A-C
- •Child-Pugh sore ≤ 6
- •Percentage of lymphocytes in peripheral blood ≧12%.
- •Performance status ECOG ≦2
- •AST and ALT ≦ 5x upper limit of normal.
- •Platelet ≥ 80000/mm3
- •WBC ≥ 3000/uL
- •RBC ≥ 2.5x106/uL
- •eGFR ≥ 30ml/min/1.73m2
- •The patients must be disease-free after liver resection, which is confirmed by dynamic CT or MRI within 14 days.
- •The participants must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely.
- •The participants must agree to harvest and preserve tumor specimens during operation.
排除标准
- •Subjected having other malignancies except HCC are excluded.
- •Uncontrolled or clinically significant cardiac diseases.
- •Positive for HIV.
- •Active bacterial of fungal infections.
- •Prior chemotherapy within one month.
- •Use of other investigational drugs within one month.
- •Subjects with systemic steroid treatment within 14 days.
- •Subjects in the status of immune deficiency.
- •Subjects in the status of autoimmune diseases.
- •Subjects with long-term use of immunosuppressive agents.
- •Subjects with checkpoint inhibitor immunotherapy within one month.
- •Subjects with local regional therapy within one month.
研究组 & 干预措施
Autologous Dendritic Cell Therapy
Participants will receive a total of 3 courses of autologous dendritic cell vaccination. For each course, peripheral blood (50-60 ml) is drawn for dendritic cell culture, followed by an intravenous injection of the cultured dendritic cells.
干预措施: Autologous Dendritic Cell (Biological)
结局指标
主要结局
Disease-free survival
时间窗: From date of randomization untill the date of radiographic tumor assessment confirm tumor recurrence, assessed up to 3 years
Disease-free survival
时间窗: From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years
次要结局
- Overall survival(3 years)
- Overall survival(From date of surgery to death from any cause, assessed up to 3 years)
研究者
Wei-Chen Lee
Principal Investigator, Clinical Professor
Chang Gung Memorial Hospital