CTIS2023-506979-10-00进行中（未招募）1 期
A phase I/II trial of peri- and postoperative treatment with histamine dihydrocloride and low-dose interleukin-2 in patients with primary resectable pancreatic cancer.
Vaestra Goetalandsregionen0 个研究点目标入组 50 人开始时间: 2024年2月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution., 2.Patient is a male or female age >18, 3.By the surgeons evaluation fit for pancreatic surgery, 4.Subjects must have radiologic, and/or cytologic confirmation of primary resectable pancreatic or periampullary cancer. Pancreatic ductal adenocarcinoma, ampullary carcinoma and cholangiocarcinoma are the most common forms, but also other rare forms of pancreatic and periampullary cancer may be included.
排除标准
- •1.Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 6 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease., 2.History of uncontrolled seizures, severe central nervous system disorders, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol., 3.Ongoing treatment with immunomodulating medication, i.e. corticosteroids., 4.Ongoing active peptic ulcer., 5.Ongoing asthma., 6.Any other condition or symptoms preventing the patient from entering the study, according to the PI's judgement., 7.A woman of childbearing potential (WOCBP) must agree to comply with using an effective contraceptive method for the duration of the treatment (a WOCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Local laws and regulations may require use of alternative and/or additional contraception methods. One of the highly effective methods of contraception listed below is required during study duration and until the end of relevant systemic exposure, defined as 5 months after the end of study treatment.
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