NCT06346808尚未招募1 期
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer
Sichuan University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
研究概览
简要总结
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and age ≤75 years. ECOG score 0-
- •Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer
- •Adequate bone marrow and organ function:
- •Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
- •Signed informed consent. Ability to comply with the study protocol and follow-up.
排除标准
- •Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
- •Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
- •Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
- •Serious uncontrolled medical conditions that may interfere with the subject's ability to receive treatment as specified in the protocol, including, but not limited to, positive HIV test, active tuberculosis, and DNA copy number of HBV >103/ml;
- •Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
- •Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
- •Pregnant or lactating women;
- •Those who may be allergic to the study drug or any of its excipients;
- •Preoperative ultrasound evaluation of patients with small tumor size, location near or behind major blood vessels, and various other factors that may result in a low success rate of intra-tumoral viral injection under ultrasound and a high rate of post-injection complications;
- •Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
- •Any uncertainty that affects patient safety or compliance.
研究组 & 干预措施
Oncolytic virus Plus Anti-PD1 and Chemotherapy
Experimental
Oncolytic virus d1 ;Camrelizumab 200mg, d2+AG(Gemcitabine d2/9+Capecitabine d2-d15),q3w；up to 4 cycles;
干预措施: Oncolytic virus Plus Anti-PD1 and Chemotherapy (Drug)
结局指标
主要结局
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
时间窗: through study completion, an average of 1 year
Defined by treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- R0 resection rate(6 months)
- ORR(6 months)
研究者
Zhen-Yu Ding
Professor
Sichuan University
研究点 (1)
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