Archives: Clinical Trials

This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

This study is a single-arm, open, single-center clinical study to observe and evaluate the efficacy and safety of sovalteinib in combination with solutumab and tegeo in second-line and post-line treatment of patients with advanced pancreatic cancer.

A total of 30 patients were enrolled in this study, which was divided into 3 phases: screening phase, treatment phase and follow-up phase. During the treatment period, tumor status was evaluated by imaging methods every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during patient treatment) or intolerable toxicity, and tumor treatment and survival status after disease progression were recorded. Safety observations included AE, changes in laboratory test values, vital signs, and changes in ECG. In addition, 10 ml of blood was drawn for testing in our laboratory before each treatment and at the time of disease progression before the patients were enrolled, and the exploration of the efficacy-related biomarker BRCA1 was performed by blood samples.

The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.

Pancreatic adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality in the United States. The high mortality for these tumors is primarily attributed to the late stage in which most patients are diagnosed, leading to a dismal 5-year survival of 6% for all stages of PDAC. Surgical resection offers the best chance for survival, but most patients only present with symptoms after the tumor has metastasized, and as a result are not operative candidates. This creates a need to both identify patients at an earlier stage while their cancer is still resectable, and predict the aggressiveness of the disease in order to better target treatment. In addition, even patients who receive curative surgery are at a high risk of developing recurrence of disease. Thus, there is also a need to detect recurrence early so appropriate treatment can be provided. As several adjuvant chemotherapeutic regimens are now available, it will be important to identify as soon as possible that the cancer has become refractory to a given therapy. This will allow one to progress to second or third line therapy more quickly while the tumor burden is smaller. This purpose of this study is to identify biomarkers in the blood of patients with PDAC and determine how they can change over time in relation to treatment to assess for any correlation with patient outcomes, response to treatment, recurrence of disease and overall survival. This study will be limited to patients who present to the Johns Hopkins Hospital between January 1, 2015 and December 31, 2018 with PDAC. Blood will be drawn from all consenting patients at the time of initial diagnosis and after treatment. Patients will undergo treatment for their cancer based on personal preference, standard guidelines and discussion with medical, radiation, and surgical oncologists. Patients who undergo surgical resection will also have an additional blood sample collected after resection, and patients who undergo chemotherapy and/or radiation will have an additional blood sample draw at the end of this treatment. A patient could have blood collected at multiple intervals, i.e. a pre-treatment sample, sample post-neoadjuvant chemotherapy/radiation, sample post-surgery, and sample post-adjuvant chemotherapy/radiation. In patients, who have undergone curative resection of PDAC blood samples will be collected till they develop clinical recurrence of disease. For the first 2 years following surgery samples will be collected every 3-4 months. Beyond that the investigators will collect samples every 6 months for the next two years. For all patients found to be alive and disease free beyond 4 years after surgery samples will be collected once every year. These patients will be followed to determine disease-free and overall survival. With this study, the investigators aim to assess the potential utility of blood biomarkers over time for pancreatic tumors which will help both with early detection of disease and also recurrence of disease after surgery. Biomarkers identified would have the potential to create a new method for early diagnosis of patients with PDAC, predict overall survival, response to treatment, or risk of metastatic spread, and predict recurrence of disease, all of which has the potential to drastically improve outcomes for this deadly disease.

The investigators are going to explore the diagnostic and prognostic value of circulating tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic ultrasound in pancreatic cancer patients.

The objectives of this study are to study the safety and effect of IRE as a treatment for inoperable hepatic and pancreatic malignancy.

The aim of the study is to identify how often gastrointestinal problems interfere with quality of life as a result of treatment for cancer with chemotherapy. We also want to identify the causes for these symptoms and see if simple treatments used for other gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it can cause a whole range of physical side effects. Probably the most common side effects are those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy but research discovered a whole series of new treatments so that severe vomiting from chemotherapy is rarely a problem today. However, patients can develop a whole series of other symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the lavatory and opening the bowels very frequently. The causes for these symptoms have hardly been studied even though they sometimes affect people quite badly. In our specialist gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We would like to extend these methods to people having chemotherapy. We have identified several easily treatable causes for these symptoms after radiotherapy, which previously were often ignored. We believe that some of these causes also occur in people having chemotherapy and if we knew how often they do occur we could focus on improving treatment for affected people. We plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people who are troubled by any or some of these symptoms we will arrange simple series tests which could sort out why these symptoms occur and we will record how they respond to treatment.

The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced pancreatic cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1 bispecific antibody for pancreatic cancer.

Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This &#x0022tells&#x0022 the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments.

The main aims of the study are:

* To check the safety of ASP2138 and how well people can tolerate medical problems during the study.
* To find a suitable dose of ASP2138 to be used later in the study.
* These are done for ASP2138 given by itself and when given together with the standard cancer treatments.

Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a &#x0022trigger&#x0022 such as infection, or have a specific heart condition (&#x0022New York Heart Association Class III or IV&#x0022).

Phase 1: Lower to higher doses of ASP2138

* ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection).
* Different small groups are given lower to higher doses of ASAP2138.
* ASP2138 is either given by itself, or given with 1 of 3 standard treatments:
* Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer)
* Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer)
* ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer)

Phase 1b: doses of ASP2138 worked out from Phase 1

* ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1.
* People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1.
* This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments.
* The standard cancer treatments given depends on the type of cancer they have.

End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment.

People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.