Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.
This phase II trial studies how well epacadostat and pembrolizumab work in treating participants with pancreatic cancer that has spread to other places in the body. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving epacadostat and pembrolizumab may work better in treating participants with pancreatic cancer.
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.
As short term endpoints: postoperative complications and resumption of bowel function.
Long term endpoints include: 1 and 3 year recurrence and mortality.
The investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).
This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin, given in conjunction with radiation therapy, for treating patients with cancer of the pancreas. Gemcitabine is standard therapy for advanced pancreatic cancer. It damages tumor cells and may enhance the effects of radiation therapy. Herceptin is a genetically engineered antibody that has prevented some tumors from growing in patients with breast cancer. Because breast and pancreatic cancer cells share an characteristic related to how Herceptin works (similar HER-2/neu receptor proteins), it is thought that this drug may also inhibit growth of tumors of the pancreas.
Patients with pancreatic cancer may be eligible for this study. Candidates will be screened with a physical examination, chest X-ray, blood tests, electrocardiogram, and computerized tomography (CT) scan of the chest, abdomen and pelvis. They will also have a minor surgical procedure called a laparoscopy to evaluate the extent of their cancer. This procedure, done under general anesthesia, requires an overnight hospital stay. A small incision (about 1 inch) is made in the abdomen and a thin, flexible tube with a light and special fibers at the end is inserted into the opening. This device, called a laparoscope, allows the surgeon to see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of tumor tissue for examination.
Patients accepted into the study will be assigned to one of two treatment groups, according to whether or not their tumor can be removed with surgery. Patients will be asked to complete a Quality of Life Evaluation before treatment begins and again at each follow-up visit. This 15-minute questionnaire assesses patients' feelings, their ability to carry out usual activities, and the effects of therapy on their general health and well being.
Patients in both treatment groups will be given the same chemotherapy, on an outpatient basis unless special circumstances require hospitalization. Gemcitabine is infused over 30 to 60 minutes through an intravenous catheter (IV)-a thin plastic tube inserted into an arm vein. Herceptin is then given over 30 to 90 minutes through the same IV line. Radiation therapy to the abdomen will start the same day, after the drugs have been administered, and will continue for the next 4 days. This treatment cycle-chemotherapy plus 5 days of radiation therapy-will be repeated each week for 6 weeks.
Within 6 weeks after the last treatment, the patient's tumor will be evaluated with a blood test and CT scan of the chest, abdomen and pelvis to determine if it can be removed with surgery. If so, the procedure will be done under general anesthesia and will require a 7- to 10-day hospital stay. If the tumor cannot be removed with surgery, another biopsy will be taken to evaluate the tumor's response to the chemotherapy and radiation treatment.
All patients will receive additional chemotherapy beginning 6 weeks after surgery (for patients whose tumors were removed) or 6 weeks after radiation therapy (for patients whose tumors could not be removed). Gemcitabine and Herceptin will be given IV once a week for 3 weeks followed by a week of rest. This 4-week treatment cycle will be repeated up to six times.
After treatment ends, patients will be evaluated with CT scans or X-rays and blood tests every 3 to 4 months for the first 2 years and every 6 months thereafter to evaluate disease status.
1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
2. Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
Rational:Pancreatic cancer is a systemic disease at the time of diagnosis, even among patients with apparent localized disease. Surgical resection is the only potentially curative therapy for pancreatic cancer, but in patients who undergo surgery and postoperative therapy, metastatic relapse remains common and no more than 20% of patients achieve 5-year survival.
Because of this aggressive biologic behavior, an increasing interest is growing about preoperative treatments in resectable pancreatic cancer.
The combination chemotherapeutic regimen with irinotecan + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin (FOLFIRINOX) is an effective choice for first line treatment in patients affected by advanced pancreatic cancer, and in this setting it achieved a Disease Control Rate of 70.2 % (10). In this regard, FOLFIRINOX is currently explored as preoperative regimen in a number of clinical trials in resectable pancreatic cancer.
A critical challenge in this field remains the introduction in these combination treatments of the most novel and effective agents such as nalIRI, in order to obtain a more profound tumor shrinkage, to increase the rate of R0 resections, to allow an early treatment of occult micrometastatic disease, and eventually, to improve survival in patients with resectable pancreatic cancer.
This study proposal is designed to address this challenge. Preliminary results, collected during the Part 1 Dose Escalation of a current clinical trial performed in mPDAC, show that dose of nal-IRI: 60 mg/m2, Oxaliplatin: 60 mg/m2, 5-FU/LV: 2400/400 mg/m2 is safe.
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.
