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Pancreatic Neoplasms clinical trials

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NCT ID: NCT03679910 Recruiting - Pancreas Cancer Clinical Trials

Evaluation of CEMIP in Pancreatic Cancer

Start date: January 1, 2019
Study type: Observational

Pancreatic cancer (PC) is one of the most lethal diseases among all cancer types. The diagnosis of PC is usually based on radiology or invasive endoscopic techniques. Various types of tumor markers are used for diagnosing PC. The tumor markers carbohydrate antigen19-9 (CA 19-9) and carcinoembryonic antigen (CEA) are the ones most closely tied to PC. These tests are more often used in people already diagnosed with pancreatic cancer to help tell if treatment is working or if the cancer is progressing . Cell migration inducing protein (CEMIP) has been reported to be associated with early detection, cancer cell migration, invasion, and poor prognosis. Aim of the work: - To Estimate the level of CEMIP, CA19-9 and CEA in pancreatic cancer patients. - To evaluate the clinical utility of serum CEMIP, CA19-9 and CEA in pancreatic cancer patients in comparison with healthy controls and their relation to cancer staging and histopathological types. - To detect the correlation between CEMIP, CA-19-9 and CEA.

NCT ID: NCT03679169 Not yet recruiting - Pancreatic Cancer Clinical Trials

Evaluation of Complete microscopicE Resection Margin (R0) and Lymph Node Involvement After Standard Pancreatosplenectomy (SPS) Versus Radical Anterograde Modular Pancreatosplenectomy

Start date: October 2018
Phase: Phase 3
Study type: Interventional

Resection with negative margins (R0) followed by adjuvant chemotherapy is today the standard of care and the only chance of cure for patients with pancreatic ductal adenocarcinoma (PDA). Incomplete microscopic resection margin (R1) after pancreatic resection has been reported to occur in 17 to >80% of cases depending on the nonconsensual definition of R1 status. This discrepancy is reflected in conflicting reports regarding the prognostic relevance of R1 resection. Currently, neither the definition of the margin involvement nor the surgical technique to clear the margins is consistently applied, resulting in conflicting data in the literature. The Radical Antegrade Modular Pancreatosplenectomy (RAMPS) was described by Strasberg et al. in 2003 to increase the rate of R0 resection for left PDA. However, there is no grade A recommendation and surgical practices still remain heterogeneous as many surgeons still consider the "retrograde" technique as the standard procedure. The invasion of the resection margins is often poorly evaluated, including in large clinical trials. The surgical specimens are not systematically inked and the microscopic invasion of the splenic vessels is underreported, leading to inaccurate pathologic evaluation. A French prospective multicenter study (Delpero JR et al; NCT00918853) was previously conducted for pancreaticoduodenectomy specimens. A recent update (Ann Surg 2017, in press) has emphasized the value of a standardized pathology protocol to accurately assess the impact of R0 resection and improve patient's stratification. Today, no recommendations are available regarding the surgical procedure and histological analysis for DP specimen handling. The primary endpoint of this multicenter randomized control trial (RCT) is to investigate the benefit of the RAMPS procedure in comparison to standard distal pancreatosplenectomy (SDPS) on the R0-resection rate using a high-quality pathology protocol. To date, there are no prospective data assessing the superiority of the RAMPS technique over standard resection. This study will be the first RCT on the subject. This study could improve the surgical practices and define a surgical standard of care. The pathology protocol used for the study could help to standardize histopathology report on margin status. It could also provide a better evaluation of the impact of adjuvant and neoadjuvant therapies on local control. This study should lead to improved selection of patients for upfront surgery and give appropriate perioperative treatment tailored to a well-defined disease stage. Furthermore, guidelines for surgical practices and standardization of histological examination may represent a significant step forward in the design of future trials to assess perioperative strategies.

NCT ID: NCT03673423 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer

Start date: September 5, 2018
Study type: Observational

Assess the degree of vascular involvement is crucial in the diagnostic and therapeutic work-up of pancreatic cancer. NCCN resectability classification is used to stratify patients (in resectable, borderline resectable and non resectable) and is based on contrast-enhanced CT scan images. Unfortunately evaluation of imaging tests may rely on some degree of subjective interpretation by observers implying a fundamental variation in patient's treatments and an irreproducibility of different center study results. This is a multicenter diagnostic study on interobserver agreement on the resectability of pancreatic cancer based upon NCCN criteria. The primary aim of the study will be the assessment of interobserver variability to define vascular invasion and resectability status on CT scans (according to the last version of the NCCN Classification). One hundred and thirty eight consecutive patients, able to produce an informed consent, from 18 years of age, with a non-metastatic pancreatic adenocarcinoma assessed by a contrast-enhanced high-quality CT scan will be enrolled. 69 CT scan studies provided by the centers involved (High volume for pancreatic surgery) will be randomly selected from a pool of 138 of the patients that meet the inclusion criteria. Each study will be independently reviewed by a senior radiologist and a senior surgeon of each center, blinded to patient's clinical history and CT scan report, using NCCN definition of respectability status. A CFR will be filled during the review and send to the study coordinator. The data will be than centrally analyzed to asses interobserver agreement The enrolment phase will last 6 months and the whole study will last 8 months.

NCT ID: NCT03668418 Recruiting - Pancreatic Cancer Clinical Trials

Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos

Start date: June 1, 2018
Study type: Observational

The study consists in a co-clinical trial by using zebrafish embryos. Specifically, an observational prospective clinical trial on patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers undergoing a chemotherapy treatment will be run concurrently to an animal trial on zebrafish embryos xenotransplanted with patient cancer cells in order to demonstrate that zebrafish model is able to predict the therapeutic regimen with the best efficacy for each patient.

NCT ID: NCT03666832 Not yet recruiting - Clinical trials for Metastatic Pancreatic Cancer

Multi-center, Open-label, Phase 1b Clinical Trial to Evaluate the Safety, Tolerability, and Exploratory Efficacy of TEW-7197 in Combination With FOLFOX in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed First-Line Gemcitabine and Nab-Paclitaxel

Start date: September 17, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

- Inclusion 1. Subjects who are males or females ≥ 19 years of age 2. Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma 3. Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial 4. Subjects who have the following laboratory test values: - bilirubin ≤ 1.5 x ULN (upper limit of normal) - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN - serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault) - partial thromboplastin time (aPTT) ≤ 1.5 x ULN - absolute neutrophil count (ANC) ≥ 1,500 cells/µL - platelet count ≥ 100,000/µL - hemoglobin ≥ 9.0 g/dL 5. Subjects who have at least a 12-week life expectancy at the Investigator's discretion 6. Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1 - Exclusion 1. Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed) 2. Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks) 3. Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin 4. Subjects who have moderate or severe cardiovascular disease - Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening - Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening - Subjects who have increase in brain natriuretic peptide(BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based on the normal range of relevant study center) - Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis - Subjects who have a history of heart or aorta surgery 5. Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening 6. Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s) 7. Subjects who have received prior treatment targeting the signaling pathway of TGF-β 8. Subjects who have a disease or condition that affects the mechanism of the investigational product, or are currently using or planning to use: - Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme (CYP) including CYP1A2, CYP2B6, or CYP3A4 - Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase (UGT) 1A1 (UGT1A1) - Drugs that are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1 - Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4 9. Subjects who are unable to swallow tablets 10. Subjects who have a history of or are suspected of drug abuse 11. Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period (e.g., sterilization, intrauterine contraceptive device, combination of oral contraception and barrier contraception, combination of other hormone delivery systems and barrier contraception, contraceptive cream, combination of cream, jelly, or form and diaphragm or condom) 12. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study 13. Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product

NCT ID: NCT03665571 Recruiting - Clinical trials for Pancreatic Neoplasms

Evaluation of Killing Activity of Expanded Natural Killer Cells From Blood in Patients With Pancreatic Cancer

Start date: July 2016
Study type: Observational [Patient Registry]

Pancreatic cancer, one of the deadliest epithelial malignancies, has a 5-year survival rate of only about 8%. The mortality rate has decreased slightly, but the incidence rate has been steadily increasing, and it is predicted to be the second leading cause of cancer mortality in 2030. Early diagnosis of pancreatic cancer and the development of innovative therapies are needed, and various basic and clinical studies based on pancreatic cancer biology are underway. Recently, studies on the effect of natural killer (NK) cells on cancer progression and the development of therapeutic agents using them have been actively conducted. NK cells are a component of innate lymphoid cells, accounting for approximately 5-15% of total peripheral blood mononuclear cells (PBMC).

NCT ID: NCT03662412 Recruiting - Pancreatic Cancer Clinical Trials

Study of Sirolimus in Patients With Advanced Pancreatic Cancer

Start date: June 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Pancreatic cancer is a highly malignant tumor of the digestive system.In China, the annual mortality/morbidity of pancreatic cancer is as high as 0.88:1, and the morbidity and mortality are still on the rise. The 5-year survival rate of pancreatic cancer patients in the United States is only 8%, among which more than 50% of patients have distant metastasis at the time of diagnosis, and the 5-year survival rate of advanced patients with distant metastasis is as low as 3%, with extremely poor prognosis. Currently there is no standard treatment for the first - and second-line treatment resistant and postoperative recurrent patients to further prolong their survival. mammilian target of rapamycin (mTOR) is a very important serine/threonine protein kinase involved in the regulation of energy metabolism, cell growth, angiogenesis and other cellular biological processes.Rapamycin (sirolimus) is a selective inhibitor of mTOR kinase, which can inhibit the activation and proliferation of T lymphocytes to inhibit the immune response.Currently, mTOR inhibitors are also widely used in tumor treatment. Several studies have been performed to evaluate the efficacy of sirolimus in some solid tumors, and encouraging results are obtained. However, the existing studies on mTOR inhibitors and pancreatic cancer treatment are mostly phase I trials, with little evaluation of the efficacy. Therefore, the phase II clinical trial of rapamycin in the treatment of pancreatic cancer is very necessary. In preclinical studies, investigators found that rapamycin can effectively inhibit the angiogenesis of liver Cancer led by tumor-associated macrophages (TAM), thereby inhibiting the progression of liver Cancer.In vitro experiments on pancreatic cancer showed that rapamycin can directly inhibit the proliferation of pancreatic cancer cells.After the treatment with rapamycin in the homologous xenograft tumor model of mice, it was found that the tumor growth of mice was significantly inhibited. Further analysis suggested that rapamycin not only directly inhibits tumor proliferation, but also reverses the immune suppressive microenvironment of pancreatic cancer and promotes the T-cell-mediated anti-tumor immune response.Preclinical findings suggest that rapamycin may benefit survival in pancreatic cancer patients, which makes us very interested in the efficacy of rapamycin in patients with advanced pancreatic cancer.Therefore, investigators designed this trial to evaluate the clinical efficacy of rapamycin in patients with second-line resistance and recurrence who lacked a standard treatment regimen.

NCT ID: NCT03662204 Recruiting - Breast Cancer Clinical Trials

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Start date: August 23, 2018
Study type: Observational

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

NCT ID: NCT03662035 Not yet recruiting - Clinical trials for Advanced Pancreatic Cancer

Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer

Start date: September 15, 2018
Phase: Phase 2
Study type: Interventional

The aim of this study was to determine the efficacy and safety of apatinib combined with S-1 on advanced pancreatic cancer patients after failure of first-line chemotherapy.

NCT ID: NCT03659903 Completed - Pancreas Cancer Clinical Trials

Pancreaticoduodenectomy in Elderly Pancreatic Ductal Adenocarcinoma Patients

Start date: January 1, 2004
Study type: Observational

We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013All the malignant cases were followed-up annually to determine vital status. The aim of Our study is to make clearly the long-term survival of younger (age <80 years) and elderly (age ≥80 years) pancreatic cancer patients underwent PD. Sec-ond, find out the risk factors of poor prognosis in elderly patients.