Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.
详细描述
Background and aim:
Pancreatic cancer, characterized by its aggressive nature and dismal prognosis, exhibits one of the lowest 5-year survival rates among all solid tumors, standing at a mere 7%. Alarming projections suggest that by the year 2030, it will ascend to become the second leading cause of cancer-related deaths. This dire scenario is further compounded by the stealthy onset of the disease, with an overwhelming 80-85% of patients already presenting with unresectable pancreatic cancer at the time of initial diagnosis.
Clinical trials have endeavored to extend the survival of this challenging patient subset through the administration of chemotherapy or chemoradiotherapy. While these interventions have shown some promise, the overall response rate remains disappointingly low, and patients continue to grapple with a bleak prognosis, often surviving less than a year. This unmet medical need underscores the critical demand for more effective therapeutic modalities in the management of pancreatic cancer, as the lack of viable treatment options remains a primary driver of its high mortality rate.
The traditional therapeutic landscape for unresectable pancreatic cancer primarily relies on single-agent chemotherapy. However, there is a growing realization within the medical community that a paradigm shift toward a multidisciplinary approach is imperative. The crux of achieving long-term survival for pancreatic cancer patients lies in the attainment of a durable anti-tumor response.
Targeted PD-(L)1 immunotherapy, renowned for its ability to induce enduring anti-tumor responses by harnessing the body's own immune system, has yielded remarkable results in various malignancies. Paradoxically, the success of single-agent immunotherapy in pancreatic cancer has been elusive, a phenomenon possibly attributed to the tumor's intrinsic genetic mutations and the hostile, immunosuppressive microenvironment that envelops pancreatic tumors.
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
- •ECOG PS 0-1
- •Pathological tissue-confirmed unresectable locally advanced pancreatic cancer
- •Pancreatic cancer patients who have not received systemic anti-tumor therapy
- •Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards
- •A life expectancy of > 3 months
- •Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells/L, platelets ≥ 75×109 cells/L, hemoglobin ≥ 9.0 g/dl
- •AST<2.5 × ULN(Upper Limit of Normal), ALT<2.5 × ULN,creatinine ≤1.5xULN, total bilirubin < ≤1.5 X ULN.
排除标准
- •Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment
- •Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment
- •Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors
- •Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment
- •Abnormal results of blood routine examinations and liver and kidney and coagulation tests
- •Abnormal function of major organs (14 days before enrollment)
- •Women who are pregnant
- •Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
研究组 & 干预措施
Sintilimab Plus Chemotherapy and Radiotherapy
Sintilimab Plus mFFN or NALIRIFOX and Radiation
干预措施: Sintilimab Plus mFFN or NALIRIFOX and Radiation (Drug)
结局指标
主要结局
PFS
时间窗: 2 year
Time from first dose of study drug to first radiographic disease progression or death, whichever occurs first
AE
时间窗: 2 year
Advent event rate
次要结局
- Overall survival(2 year)
- Duration of response(2 year)
- Disease control rate(2 year)
- Overal response rate(2 year)
研究者
Jinbo Yue
Jinbo Yue
Shandong Cancer Hospital and Institute