Active clinical trials for "Pancreatic Neoplasms"

Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172 new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20% of pancreatic cancer patients present at a disease state that allows surgical resection while 30% have locally advanced, unresectable disease and 50% show distant metastases. While the latter two are currently treated in a palliative setting with median survival of at most 6-12 months, patients who undergo tumor resection with curative intentions also achieve only 5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought to be chemoresistance, early establishment of metastatic disease, and importantly, high rates of R1 resections. Up to 80% of pancreatic resections have positive resection margins which are often found within the vascular groove and/or at the retroperitoneal margin, close to the superior mesenteric artery. This high rate of positive margins is only found after meticulous pathological work-up and is normally not detected after standard assessment of the specimen. However, the clinical importance of the high positivity of resection margin is even more highlighted as patients undergoing portal vein resection despite negativity of portal vein invasion after regular pathological work-up show significantly better survival compared to patients without portal vein resection. In sum, given the overall poor prognosis despite tumor resection, auxiliary treatment strategies to improve long-term outcomes are desperately needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a non-thermal ablative modality that allows local tumor destruction with sparing vital structures like arteries, venous vessels, as well as the bile and pancreatic duct. There is increasing evidence that IRE for locally unresectable pancreatic cancer is effective with an increase in local progression free survival , distant progression free survival and overall survival compared to historic controls.Data on margin accentuation IRE are sparse while in a recent study published by Martin et al showed that margin accentuation among patients with borderline resectable disease can be performed safe and efficacious if the treatment can be performed "with a high degree of technical ability and skill set".

This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel platinum product, in patients with advanced solid tumors and BRCA or other DNA repair mutation. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety, pharmacokinetics and the anti-cancer activity of BTP-114.

Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Preclinical studies demonstrated diaphragmatic muscle wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia models.(40) Many patients, who experience cancer cachexia, describe a generalized debility and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as measured by pulse oximetry. Whether this is related to deconditioning associated with chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains unknown. In this pilot study, the investigators propose to perform a preliminary evaluation of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop cachexia, to assess for the feasibility of performing a larger prospective study to understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to develop pharmacological or exercise based interventions to prevent or delay its progression. Based on clinical experience and published literature, it is expected that 60-70% of patients will have >10% weight loss during the course of this disease. More commonly, this is associated with clinical or radiographic disease progression, but certainly it can happen throughout the course of the disease even without disease progression.

Currently, for patients with pancreatic cancer the standard treatment is surgery followed by chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery and treat the area of the tumor with intraoperative radiotherapy in one procedure. Intraoperative radiation delivers low energy x-rays to a targeted area during the time of tumor removal. The purpose of this study is to learn about both the good and bad effects of adding intraoperative radiation therapy. Another goal is to determine and compare the quality of life before and after the procedure. We will also monitor the effect of the therapy on the cancer lesion and any complications that may result.

Up to 13.5% of patients that undergo a magnetic resonance imaging (MRI) scan of their abdomen without pancreatic symptoms are found to have an incidental pancreatic cyst, with the frequency increasing with age. In a post-mortem series, 25% of patients had a pancreatic cyst, of which 32% were potentially premalignant and 3% malignant. Premalignant cysts are currently either observed or removed surgically according to international guidelines. Observation is associated with significant anxiety for patients and a growing cost to the National Health Service, while surgery for this usually benign condition is associated with not insignificant morbidity and mortality. Premalignant pancreatic cysts may be indolent for a number of years before malignant transformation, creating a window of opportunity for minimally invasive intervention and cure. New early treatment options for premalignant tumours are urgently required. This study will evaluate the safety and efficacy of a novel minimally invasive technique for the treatment of pancreatic cystic tumours; endoscopic ultrasound guided radiofrequency ablation (EUSRFA). If successful it will offer an alternative to long term observation or surgery for patients with this condition.

This is phase II study on the efficacy of octreotide lar as maintenance treatment after first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic or esophageal neuroendocrine carcinomas.

The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months. Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the early 1990s. Other studies have investigated its role in diseases of the colon and esophagus. More recently, this technique has been recognized for its potential in palliative treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea, recently. The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in patients with malignant biliary strictures.

<Part I - Phase I trial> The phase I clinical trial is to identify the MTD (Maximum Tolerated Dose) and DLT (Dose Limiting Toxicity) of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose level. Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects. <Part II - Phase II trial> In the phase II clinical trial, the subjects will be administered with the dose which is to be identified as a recommended dose based on the results of Phase I study. The whole one cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles and tumor assessment is evaluated every 2 cycles.

The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118 alone or in combination with pancreatic cancer chemotherapy.