Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Overall survival，OS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.
详细描述
Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.
Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Combination of PD-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer.
The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document.
- •Age ≥ 18 years and ≤ 80 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
- •Patients who have received at least two lines of anti-tumor chemotherapy, or patients who have been unsuitable or unwilling to standard therapy.
- •Locally advanced, or metastatic pancreatic cancer.
- •Presence of at least of one measurable lesion in agreement to RECIST criteria.
- •The expected survival ≥ 3 months.
- •Adequate organ performance based on laboratory blood tests.
- •Patients who are willing or able to comply with study procedures.
排除标准
- •Pregnant or nursing women.
- •Primary pancreatic cancer, or prior treatment with oncolytic virus and PD-1 inhibitor.
- •The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- •Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- •Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- •Allergic to study drugs.
- •Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
研究组 & 干预措施
Oncolytic virus plus PD-1 inhibitor
- H101 intratumorally injection starts at day 1.
- Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
- After two cycles of treatment, Camrelizumab will be administered alone at 200 mg i.v. every 3 weeks from cycle 3 until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- The following treatment will be applied according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline.
干预措施: H101 (Drug)
Oncolytic virus plus PD-1 inhibitor
- H101 intratumorally injection starts at day 1.
- Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
- After two cycles of treatment, Camrelizumab will be administered alone at 200 mg i.v. every 3 weeks from cycle 3 until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- The following treatment will be applied according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Overall survival，OS
时间窗: At the end of Cycle 1 (each cycle is 21 days)
OS of subjects from recruiting to the time of death from any cause
次要结局
- objective response rate (ORR)(At the end of Cycle 1 (each cycle is 21 days))
- progression-free survival, PFS(At the end of Cycle 1 (each cycle is 21 days))
- disease control rate (DCR)(At the end of Cycle 1 (each cycle is 21 days))