A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.
详细描述
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.
The study is planned to enroll 10 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 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
- •Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- •Males and females≥18 years of age, inclusive, at the Screening Visit.
- •Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology.
- •No prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer.
- •Have at least one measurable lesion according to RECIST v1.1 criteria.
- •An Eastern Cooperative Oncology Group (ECOG) score of 0 or
- •Expected survival time of≥3 months.
- •No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.
排除标准
- •Have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ.
- •Previous treatment with other oncolytic viruses.
- •Immunocompromised patients.
- •Known alcohol or drug dependency.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
VRT106 combination with chemotherapy
VRT106 combination with chemotherapy
干预措施: Oncolytic virus VRT106 (Drug)
VRT106 combination with chemotherapy
VRT106 combination with chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: About 3 years
Incidence rate of TRAE
次要结局
- Overall survival rate(About 3 years)