A Single Arm, Open, Exploratory Clinical Trial to Evaluate Efficacy and Safety for Combination Treatment of Replication Competent Adenovirus Double Suicide Gene Therapy(Theragene®,Ad5-yCD/mutTKSR39rep-ADP) and Radiation Therapy in Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study.
From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.
详细描述
Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with borderline resectable or locally advanced pancreatic cancer
- •Patients with histologically confirmed pancreatic adenocarcinoma
- •Patients with no evidence of peritoneal or hematogenous metastasis
- •Patients with ECOG performance status 0-1
- •Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
- •Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL)
- •Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 3 times upper limit of normal (ULN))
- •Patients with agreement with informed consent
排除标准
- •Patients with a history of other cancer
- •Patients with recurred pancreatic cancer
- •Patients with a history of radiation on more than 25% of bone marrow
- •Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy
- •Patients who have contraindication of radiation therapy
- •Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
- •Female patients with childbearing age or pregnancy or breast feeding
- •Patients who are considered as inappropriate candidate by investigators
研究组 & 干预措施
Theragene arm
Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy
干预措施: Theragene arm (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 24 weeks
the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response
次要结局
- Disease control rate(24 weeks)
- Tumor marker test(24 weeks)
- Overall survival(2 years)