Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Effect of V3-P on tumor burden
研究概览
简要总结
Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.
We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.
详细描述
This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.
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
- •diagnosis of inoperable pancreatic cancer
- •higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
- •must be able to swallow tablets
排除标准
- •negative for CA19.9
- •pregnant, breast feeding women
- •unwillingness to provide written consent
研究组 & 干预措施
Experimental
Daily tablet of V3-P given orally for 2 months
干预措施: V3-P (Biological)
结局指标
主要结局
Effect of V3-P on tumor burden
时间窗: 3 months
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer.
次要结局
- Safety of V3-P(3 months)
- Effect of V3-P on sugar and bilirubin levels(3 months)