Archives: Clinical Trials

BACKGROUND: Pancreatic Cancer (PC) is one of the leading cancer-related causes of death worldwide, with the majority of patients undergoing potentially curative surgery. In this context, the implementation of an accurate imaging modality is crucial in order to facilitate the clinical decision-making on the basis of tumor resectability. The contrast enhanced intraoperative ultrasound (CE-IOUS) is a relatively new imaging modality that has been employed in the detection mainly of colorectal liver metastases, but not for those of pancreatic origin.

AIM: The purpose of the present study is to validate the CE-IOUS in adult patients undergoing pancreatic surgery.

METHODS: Prospective single-center analysis of all consecutive patients with PC undergoing pancreatic surgery from a single hepato-pancreato-biliary (HPB) surgery team between December 1st, 2020 and December 31st, 2022 will be performed. Baseline characteristics, type of surgery, intraoperative parameters, hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative morbidity and 30-day mortality data will be obtained from the database. The primary outcome is the clinical utility, defining its ability to change surgical operation on the basis of its findings.

LIMITATIONS: The key limitation is the inclusion of only one HPB surgery team from one center.

STRENGTHS: This study will potentially be the first to evaluate EC-IOUS and to compare it with the IOUS, CT and MRI for pancreatic surgical patients.

Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

Control: Open distal pancreatectomy

The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced (unresectable and not treatable with curative intent) or metastatic urothelial bladder cancer (UBC), locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma with advanced disease where cure is no longer possible and where no other treatment options are available anymore. Participants will receive intravenous (IV) infusion of trastuzumab emtansine as Regimen A (2.4 milligrams per kilogram [mg/kg], weekly [qw]) or Regimen B (3.6 mg/kg, every 3 weeks [q3w]) until unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever occurs first. Based on tolerability and safety aspects, steering committee and Independent Data Monitoring Committee (iDMC) will decide on expansion of the study to include more participants with other carcinoma types.

This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered via the hepatic artery or splenic vein using the Surefire Infusion System (SIS) for patients with CEA-expressing liver metastases or pancreas cancer.

This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.

To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.

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.