This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has also been genetically modified with recombinant DNA to release an antigen called Mesothelin. Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at higher levels on tumor cells than on normal cells, this clinical trial will also examine if CRS 207 boosts the immune system in a way that targets certain types of cancer.
The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of the investigation agent for later clinical studies and to explore safety when given to consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer, or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor status of study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria and must have previously failed standard treatment for their cancer. Qualifying study patients will be assigned to receive one of several dose levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days apart) of CRS-207 at their assigned dose level.
This study is designed to evaluate the safety and efficacy of KN510713 in combination with mFOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer. The study will be conducted in two parts: Part 1 (Dose-finding) and Part 2 (Dose expansion).
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making.
The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.
Cancer poses a major public health challenge in China. Early detection can improve treatment outcomes and survival rates. In this study, we will conduct a large-scale, prospective, multi-center cohort study to evaluate the utility of AI-assisted non-contrast CT for multi-cancer screening.
The study aims to enroll 1 million asymptomatic participants undergoing routine health examinations, using an AI imaging model based on non-contrast CT to detect seven cancers such as lung, liver, gastric, colorectal, esophageal, pancreatic, and breast cancers. Positive cases will be required to be referred to Shanghai Changhai Hospital for further imaging and care based on National Comprehensive Cancer Network (NCCN) and American College of Radiology (ACR) guidelines. The goal is to assess the AI model's diagnostic performance for seven cancer types, especially for early-stage, resectable tumors.
This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
This study aims to know the status of BRCA and DDR genes in PDAC patients in China. Peripheral venous blood samples of the patients will be collected for next-generation sequencing of BRCA and DNA damage repair related genes. At the same time, it is necessary to record clinical information such as age, gender, tumor pathological type, tumor stage and grade, whether surgery is performed, the size of postoperative residual lesions, and treatment methods. Prognostic indicators include the association of factors such as PFS, ORR, and DCR are also recorded.
In gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs), radical surgery provides good long-term outcome and low recurrence rates. In GEP-NETs the actual surgical planning is established on the ground of preoperative morphology images (CT scan), and functional imaging using CT/PET with 68Ga-DOTA-TOC, since the high expression of somatostatin receptors (SSR) of these tumors. RGS in GEP-NETs, mainly with gamma-probes, has been not widely accepted since the low rates of sensitivity and, in particular, specificity, in discriminating tumoral/ non tumoral tissue and background ratio. This is a relevant issue in particular in detecting metastatic lymph-nodes both for small-intestine neuroendocrine tumors (SI-NETs) and pancreatic neuroendocrine tumors (Pan-NETs), where the presence of lymph-node metastases has been associated with worse long-term outcome. At present, it is not possible to distinguish whether a small lymph-node is site of metastases or not without performing frozen sections. In a previous study ex-vivo from European Institute of Oncology SI-NET presented a high uptake of a beta-emitting radiotracer, 90Y-DOTA-TOC. Five SI-NET showing SSR positivity at PET with 68Ga DOTA-TOC received 5 mCi of 90Y-DOTA-TOC the day before surgery. All the tumor samples showed high counts of radioactivity with a sensitivity of 96% and a specificity of 100%. These results allowed the investigators to develop a probe, which is now approved for in-vivo employment within the operating theatre. The objective of the present study is to verify in-vivo within the abdominal cavity the capability of the probe to detect 68-Ga activity within tumoral tissue thus favouring radical surgery and avoiding unnecessary demolition, in the near future. However, in the present protocol the entity of surgery will not be modified by intraoperative findings of the probe. It is reasonable to assume that results from 68Ga-DOTA-TOC might be comparable to 90Y-DOTA-TOC as radiotracer, and the detection efficacy of the probe for 68Ga could be not inferior compared to the isotope 90Y. However, while 90Y-DOTA-TOC is used as investigational drug for therapy purposes only within clinical research protocol, 68Ga-DOTA-TOC is a diagnostic radiotracer broadly used in day-to-day clinical practice since many years. Furthermore, the administration of 68Ga-DOTA-TOC can be directly injected in surgery room and thus does not require patients' admission the day before surgery.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.
The registry aims to collect and analyse information on the antineoplastic treatment of patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention (cohort 1) and patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention (cohort 2) in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.
RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.
