A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 73
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC).
详细描述
This clinical study is designed as a prospective, multicenter, single arm study to evaluate the clinical efficacy and safety of SBRT combined with nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). All eligible patients will receive SBRT with doses ranging from 35-40 Gy in five fractions, intravenous nimotuzumab 400mg weekly or 600mg on day 1 and 8 of a 21-day cycle, and mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression, death, unacceptable toxicity, or consent withdrawal. The main endpoint is progression-free survival (PFS).
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 18-75 years old, gender unlimited;
- •Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- •Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined;
- •The maximum diameter of the primary tumor was < 5.0cm;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •No prior radiotherapy (upper abdomen) or tumor systemic therapy;
- •Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN;
- •Left ventricular ejection fraction ≥50%;
- •Fertile subjects are willing to take contraceptive measures during the study period;
- •Woman who are breastfeeding during the study period or within 150 days after the last treatment;
- •Survival was expected to be ≥3 months;
- •12.Good compliance and signed informed consent voluntarily.
排除标准
- •Tumor invasion of gastrointestinal tract;
- •Woman who are pregnant or breastfeeding;
- •History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years;
- •History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence;
- •5.Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months;
- •Patients requiring immunosuppressive;
- •7.Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease;
- •Known allergy to prescription or any component of the prescription used in this study;
- •Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention;
- •Patients with acute and chronic tuberculosis infection;
- •Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration;
- •12.History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
- •Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration;
- •Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration;
- •15.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
研究组 & 干预措施
SBRT+Nimotuzumab+ mono-chemotherapy
All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.
干预措施: Stereotactic body radiation (Radiation)
SBRT+Nimotuzumab+ mono-chemotherapy
All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.
干预措施: Nimotuzumab (Drug)
SBRT+Nimotuzumab+ mono-chemotherapy
All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.
干预措施: mono-chemotherapy (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: Up to 12 months
PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Pain relief rate(Up to 12 months)
- Objective response rate (ORR)(Up to 12 months)
- Disease control rate (DCR)(Up to 12 months)
- adverse events(Up to 30 days after last administration)
- overall survival (OS)(Up to 12 months)