Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- overall best response rate
研究概览
简要总结
This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.
详细描述
Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors(stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).
The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with chemotherapy,or surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced stages of Oral and Maxillofacial malignant tumors (stage III and VI)
- •At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
- •Histologically confirmed Oral and Maxillofacial malignant tumors
- •No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
- •Age: 18-85 years old
- •Expected to survive more 12 weeks
- •Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
- •Subject provided signed informed consent
排除标准
- •Hypersensitive to study drug
- •Tumor(s) locate very close to important blood vessels and nerves, which affect injection
- •With a coagulation and bleeding disorder
- •With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
- •Local infection close to injection site or systemic infection
- •Pregnant or lactating
- •Principle investigator consider not suitable -
研究组 & 干预措施
surgery plus p53 gene
using p53 gene therapy before surgery
干预措施: p53 gene with surgery (Drug)
surgery alone
Surgery without pre-p53 gene therapy
干预措施: surgery (Procedure)
p53 plus chemotherapy
p53 gene therapy with concurrent chemotherapy
干预措施: p53 with chemotherapy (Drug)
p53 gene therapy alone
Intra-tumor injectio of rAd-p53 gene with no concurrent treatment
干预措施: p53 gene therapy (Drug)
结局指标
主要结局
overall best response rate
时间窗: 3 years
次要结局
- progress free survival(3 years)