Clinical Study Evaluating the Effect of Losartan on Response Rate in Both Metastatic and Locally Advanced Pancreatic Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the patient response rate
研究概览
简要总结
The pancreas is two organs packaged into one. The islets of Langerhans serve critical endocrine functions, and the exocrine portion is a major source of enzymes that are essential for digestion.
Pancreatic cancer (PC) is more commonly referred to as pancreatic infiltrating ductal adenocarcinoma in addition to being the second leading cause of cancer death in the United States, after lung cancer in 2020.
Whereas pancreatic cancer is the seventh cause of death from cancer in Asia in 2020. Although it is substantially less common than the other malignancies, pancreatic carcinoma is near the top of the list of killers because it is a highly aggressive carry.
详细描述
Pancreatic cancer has multi step carcinogenesis, starting from Pancreatic Intra-ductal Neoplasia and ends with an invasive neoplastic lesion.Pancreatic cancer is most frequent in elder people; the risk of developing pancreatic cancer goes up as people age.
It is frequently found at an advanced stage, which contributes to five-year survival rates of 2-9%, ranking firmly the pancreatic cancer among all cancer sites in terms of prognostic outcomes for patients. In addition, it has a high trend to show nodal metastasis, hepatic, bone, or pulmonary metastasis.
Epidemiological data shows that pancreatic cancer is not very common but obvious it is one of the most neoplastic death-cause in the world.The Renin angiotensin system (RAS) is an important regulator of the cardiovascular system that was identified. in this system, angiotensinogen is converted to angiotensin (Ang) I and then to Ang II by renin and angiotensin-converting enzyme (ACE), respectively.
The Ang II activates the angiotensin type 1 receptor (AT1R). It has been suggested that RAS components are involved in the evolution of various cancers and tissues, like prostate, skin, and pancreatic cancer. In the pancreas, they are considered to mediate growth and lead to carcinogenesis.
High concentrations of Ang II have been reported together with up-regulated levels of AT1R in human with pancreatic cancer and malignant pancreatic tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female pancreatic cancer patients aged ≥ 50 years old.
- •Hypertensive patient with BP ≥ 140/90 mm Hg.
- •Histologically confirmed metastatic pancreatic adenocarcinoma; or locally advanced pancreatic cancer patients.
- •All included patients must sign an informed consent
排除标准
- •Patients with serious concomitant systemic disorders as significant cardiac, renal, hepatic, or pulmonary morbidity.
- •Pregnant or lactating women and women of childbearing potential.
- •Patients received prior systemic fluoropyrimidine therapy within the past 10 years.
- •Prior un-anticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil, irinotecan, oxaliplatin, losartan, or any monoclonal antibody.
- •Patients with an active, known, or suspected autoimmune disease such as psoriasis.
- •Patients with a known positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus (HCV antibody) and patients with a known history of testing positive for (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •Patients received a live vaccine or live attenuated vaccines as intranasal influenza vaccines within 30 days of the planned start of study therapy.
研究组 & 干预措施
Group I (locally advanced PC patients):
Including three subset groups (A, B and C)
•Group I- A(control group): Fifteen hypertensive patients treated with antihypertensive agent except ARBS and ACEI with locally advanced PC on Folfirinox.
• Group I -B (are not treated with ARBs or ACEI prior PC diagnosis): Fifteen hypertensive patients with locally advanced PC and are not treated with ARBs or ACEI before PC diagnosis on the same chemotherapy treatment protocol as the control group in addition to losartan 50 mg once daily for one year after PC diagnosis.
• Group I-C (losartan was used for treatment of hypertension before and after PC diagnosis):Fifteen hypertensive patients with locally advanced PC and were treated with losartan one year before PC diagnosis on the same chemotherapy treatment protocol as the control group in addition to losartan 50 mg once daily for one year after PC diagnosis and the dose will be titrated up according to the patient's response.
干预措施: Losartan 50mg Tab (Drug)
Group II (metastatic PC patients):
including three subset groups (A, B and C):
• Group II-A (control group): Fifteen hypertensive patients treated with antihypertensive agent except ARBS and ACEI with metastatic PC on Gemcitabine hydrochloride 1 gm. vial taken as 1000 mg/m2 IV over 30 min weekly for 7 weeks.
• Group II-B (are not treated with ARBs or ACEI prior diagnosis): Fifteen hypertensive patients with metastatic PC and are not treated with ARBs or ACEI before PC diagnosis on the same chemotherapy treatment protocol as the control group in addition to Losartan 50 mg once daily for one year after PC diagnosis.
• Group II-C (losartan was used for treatment of hypertension before and after PC diagnosis): Fifteen hypertensive patients with metastatic PC and were treated with losartan one year before PC diagnosis and on the same chemotherapy treatment protocol as the control group in addition to Losartan 50 mg once daily for one year after PC diagnosis
干预措施: Losartan 50mg Tab (Drug)
结局指标
主要结局
the patient response rate
时间窗: one year
the patient response rate which will be measured using response evaluation criteria in solid tumors (RECIT 1.1).
次要结局
未报告次要终点
研究者
Mona Abd El- Rafea Abdo
Assistant lecturer of Clinical Pharmacy
Tanta University