NCT05316480尚未招募2 期
Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
详细描述
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with various types of cancer with EGFR overexpression. The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
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
- •Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with well and moderately differentiated with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
- •Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.
- •Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
- •Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- •Male or female, 18 years of age or older.
- •ECOG performance status less than
- •Life expectancy greater than 12 weeks.
- •The definitions of minimum adequacy for organ function required prior to study entry are as follows.
- •Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin < 1.5 x ULN Serum albumin > 3.0 g/dL Absolute neutrophil count (ANC) > 1500/L Hemoglobin > 9.0 g/dL Creatinin clearance < 40 mL/min
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Active second primary malignancy or history of second primary malignancy.
- •Current treatment on another clinical trial.
- •Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
- •Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
- •Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine neoplasms.
- •Patients who are unwilling or unable to comply with study procedures.
- •Prior targeted treatment on EGFR.
- •Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection.
研究组 & 干预措施
Nimotuzumab
Experimental
nimotuzumab 200mg/week
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Baseline to 6 months
Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.
次要结局
- Disease control rate (DCR)(Baseline to 6 months)
- Progression free survival (PFS)(Patients will be followed until disease progression, estimating around 12months)
- Overall survival (OS)(Patients will be followed until disease progression, estimating around 12months)
研究者
研究点 (1)
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