Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2024-07-20
2026-08-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
NCT00059982
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
NCT05074589
Locally Advanced or Metastatic Pancreatic Adenocarcinoma
NCT03559348
Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER)
NCT04106856
Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer
NCT03563248
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
AT1R is known to activate phosphatidylinositol-specific-phosphodiesterase C enzyme after being activated by Ang II to produce phosphate inositol and 2-acylglycerol, which causes the entry of Ca2+ into cells, hence, activating protein kinase C and mitogen-activated protein kinase (MAPK).
MAPK has an important role in cell proliferation. Moreover, studies show that Ang II induces Vascular endothelial growth factor (VEGF) expression which is the main growth factor involved in angiogenesis.
Several studies have reported that RAS can increase the risk of metastasis in various cancers. Building upon these findings, RAS blockers may be expected to be beneficial in pancreatic cancer treatment.
Losartan is a RAS inhibitor currently well-known to decrease blood pressure. 10 It is demonstrated in several studies that Losartan can inhibit the effect of Ang II on cell proliferation and angiogenesis. In PC, it's suggested that Losartan increases drug delivery to the tumor, thus improving the chemotherapy effect.
Furthermore it increase the efficacy of Nano-therapeutics in pancreatic cancer of mice through enhancing both interstitial and trans-vascular transport. In another study it was found that Losartan raised DNA incorporation of Gemcitabine and enhanced its efficacy.
Studies
Over the past two decades have provided important information on the potential therapeutic use of RAS blocker drugs in cancer.Extensive preclinical data support the potential use of angiotensin II receptor blockers (ARBs) as anti-neoplastic agents in pancreatic cancer
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Losartan 50mg Tab
The efficacy of losartan on response rate in both metastatic and locally advanced pancreatic cancer patients
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
Losartan 50mg Tab
The efficacy of losartan on response rate in both metastatic and locally advanced pancreatic cancer patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Losartan 50mg Tab
The efficacy of losartan on response rate in both metastatic and locally advanced pancreatic cancer patients
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mona Abd El- Rafea Abdo
Assistant lecturer of Clinical Pharmacy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Osama Mohamed Hassan, Professor
Role: STUDY_DIRECTOR
Clinical Pharmacy Department Faculty of Pharmacy, Tanta University
Sahar Mohamed El-Ghobashy, Professor
Role: STUDY_DIRECTOR
Clinical Pharmacy Department Faculty of Pharmacy, Tanta University
Mohamed Abdel Hamid Mohamed, Professor
Role: STUDY_CHAIR
Clinical Oncology Faculty of Medicine, Tanta University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tanta University Hospital
Tanta, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mona Abd El-Rafea Mohamed
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.