Clinical Trial Phase I for Evaluation of Tolerability and Safety of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03
研究概览
简要总结
Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.
Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is assessed in this study.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pancreatic cancer stage 3
- •Patients with histologically confirmed pancreatic adenocarcinoma
- •Patients with no evidence of peritoneal or hematogenous metastasis
- •Patients with ECOG performance status 0-2
- •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 < 2.5 times upper limit of normal (ULN))
- •Patients with agreement with informed consent
- •Male patients with contraception
排除标准
- •Female patients with childbearing age or pregnancy or breast feeding
- •Patients with a history of chemotherapy within 5 years
- •Patients with a history of radiation on more than 25% of bone marrow
- •Patients with unknown stage or recurrent pancreatic cancer
- •Patients with a history of skin cancer except malignant melanoma or malignancy except stage 0 cervical cancer
- •Patients with a history of major surgery except laparoscopic exam, endoscopic ultrasound, stenting, or PEG/PEJ placement
- •Patients with active or uncontrolled infection
- •Patients with immunosuppression or susceptibility to viral infection
- •Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
- •Patients with a history of allergy to clinical trial medications
- •Patients who are considered as inappropriate candidate by investigators
结局指标
主要结局
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
时间窗: 8 weeks
次要结局
- Detection of Infected Adenovirus in blood and urine assessed by PCR(8 weeks)
- Detection of adenoviral DNA in blood by PCR(8 weeks)
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03(12 weeks)
- Tumor response(8 weeks)
- Time to disease progression(6.5 months)