Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Local Control (LC)
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101.
详细描述
Patients with recurrent, radiation/chemotherapy-resistant gynecological cancer carry a poor prognosis. H101 is a recombinant human type-5 adenovirus (Ad5), in which the E1B and E3 gene have been deleted. Previous studies have shown that H101 has anticancer activity and safety in some solid tumors, but has little report in gynecological oncology. In this clinical trial, 60 recurrent or refractory gynecological cancer patients will be enrolled. Based on individual conditions, all eligible patients are intra-tumor injected oncolytic viruses H101 within 5 consecutive days combined with or without radiotherapy in sequential, three weeks for a cycle (1-4 cycles totally). Simultaneously, the tumor sample, peripheral blood, and urine specimen were collected on day1 and day5. Local control rate and side effects are recorded respectively.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Age ≥ 18 years at the time of study entry.
- •Histological or Cytologically diagnosed gynecological malignancies.
- •Failure to prior standard treatment (surgery, chemotherapy, radiotherapy);
- •Refractory/recurrence/metastasis gynecological cancer
- •At least one measurable lesion according to the RECIST1.
- •Cooperative Oncology Group-Status (ECOG Status) 0-
- •The last treatment should be over 2 weeks.
排除标准
- •History or evidence of active autoimmune disease that requires systemic treatment.
- •Participated in other anti-tumor clinical trials within 4 weeks.
- •Patients who have a contraindication to similar drugs.
- •That failure to follow up regularly.
研究组 & 干预措施
Oncorine (H101) with or without radiotherapy
The tumor mass was injected with H101 per day for 5 consecutive days, 3 weeks as one treatment cycle, and 1 to 4 cycles according to the condition of the patient, and the patient was treated with or without radiotherapy in sequential. The injection dose of H101 was determined by the tumor volume or maximum tumor diameter:5.0×10^11 virus particles(VP) for if tumor diameter≤5cm; 1×10^12 VP for the tumor diameter between 5cm and 10cm, and 1.5×10^12 VP for the tumor diameter>10cm.
干预措施: H101 (Drug)
结局指标
主要结局
Local Control (LC)
时间窗: 3 months
LC will be measured from the start date of injection until the date of progressive disease
次要结局
- Progress free survival (PFS)(12 months)
- Objective Response Rate (ORR)(1 year after injection)
- adverse events(At day 3, 7 and 30)
研究者
Liu Zi
Professor
Health Science Center of Xi'an Jiaotong University