EUCTR2017-001613-83-IT进行中（未招募）1 期
Octreotide LAR in the induction of immunologic response in patient with neuroendocrine tumors: an interventional pharmacological study - IMMUNeOCT study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •¿Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient’s awareness and willingness to comply with the study requirements.
- •¿Patients =18 years of age.
- •¿Patients with histologically confirmed well and moderately differentiated Neuroendocrine Tumors with Ki67 =/< 20% (Ki67 must be quantified in percentage) and candidates for treatment with octreotide.
- •¿ECOG performance status (PS) of 0-2.
- •¿At least 28 days since prior the last radiation therapy or surgery.
- •¿Estimated life expectancy of =12 weeks.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •¿Patients < 18 years of age.
- •¿According to the current SmPC of the prescribed drug agent.
- •¿Previuos treatment with octreotide.
- •¿Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
- •¿Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
- •¿Patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
- •¿Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
- •¿Patients with meningeal carcinomatosis
- •¿Patients with known positive HIV status
研究者
相似试验
已完成
2 期
Octreotide LAR in the Induction of Immunologic Response in NENs PatientsNeuroendocrine TumorsNCT04129255National Cancer Institute, Naples34
进行中（未招募）
1 期
The effect of pre-operative Octreotide LAR treatment on surgical cure rates of subjects with Acromegaly, and post-operative responsiveness to somatostatin analogue treatment in patients not cured surgically. - Pre-operative Octreotide LAR for AcromegalyEUCTR2005-003496-20-GBOxford Radcliffe Hospitals NHS trust
已完成
1 期
Treatment of Idiopathic Pulmonary Fibrosis with Long Acting OctreotideIdiopathic Pulmonary FibrosisNCT00463983Institut National de la Santé Et de la Recherche Médicale, France25
已完成
不适用
Investigational study on immunomodulatory effect of lenvatinib in clinical specimens - Future oriented approach for lenvatinib on tumor microenvironment and cancer regression (FLORENCE)Hepatocellular carcinomaJPRN-UMIN000044924Hiroshima University50
已完成
1 期
IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.Lung CancerNSCLCNCT01219348Inge Marie Svane14