Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism also known as compassionate use, or single patient named use. This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.
The purpose of this study is to determine whether treatment with vaccinia virus based immune system therapy Pexa-Vec followed by sorafenib increases survival compared to treatment with sorafenib alone in patients with advanced liver cell cancer, who have not received prior systemic therapy.
The goal of this study is to develop a resource bank of biospecimens blood, tissue from patients having cancers that metastasis to the liver. The purpose of the resource bank is to facilitate studies on the pathogenesis of cancers metastasizing to the liver and also in order to assess the ability of new tests to detect early cancer in the cohort of patients undergoing routine surveillance for cancer. The biospecimens will include cultures of tumor cells and tumor-associated non-malignant cells, as well as xenografts established from freshly isolated metastatic cancers in immunodeficient mice.
We plan to administer a risk factor Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care at the time of the RT planning MRI and the first clinical follow-up. An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.
The purpose of this study is to investigate means to identify circulating tumor cells from the portal vein and hepatic vein blood of patients with liver cancer at the time of liver transplantation. The primary purpose of this study is to evaluate the safety of a viral agent called vesicular stomatitis virus for the use in patients with liver cancer.
The study virus has a gene inserted into it which will allow for the production of interferon beta, which is a substance that will have the dual functions of restricting the spread of the virus to the tumor cells and not healthy liver cells and also to have some independent anti-cancer activity.
Although the primary goal of this study is to evaluate the safety of delivery of this viral agent to people, patients This study is being done to collect and store samples of blood from patients with liver disease for a research study to be able to find a new and better way to detect liver cancer.
The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma HCC after curative hepatic resection or ablation.
This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer.
Surgery, chemotherapy drugs cancer fighting medicines , and when necessary liver transplant are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere. This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or those with liver metastasis from other cancers. The drug is given intravenously, twice per week for three weeks in a row and then one week off.
Additionally patients with hematologic malignancies will be evaluated on a treatment schedule of five days in a row with two weeks off. This study will investigate if nivolumab will improve recurrence-free survival RFS compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence.
There will be a dose escalation part and a dose expansion part. The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets.
Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents or combinations with particular tumor profiles.
The purpose of this study is to investigate the value of ultrasound imaging of tumor microvasculature and stiffness as new biomarkers for evaluation of liver tumor. The goal of the study is to identify immune responses immune cell activation and suppression following local ablation of liver tumors.
The purpose of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma HCC. The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions. The purpose of this study is to evaluate the effect of Cabozantinib XL compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
The purpose of this study is to create a registry of patients with liver cancer also known as hepatocellular carcinoma and individuals with no history of liver cancer in order to characterize risk factors for liver cancer and identify biomarkers for early detection of liver cancer. The purpose of this study is to see if certain pre-transplant markers are able to predict how the kidney will respond after a liver transplant.
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. Up to 21 patients will be treated in phase 2. To determine the tumor radiotracer uptake of direct hepatic intraarterial I. The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma HCC.
The purpose of this global study is to evaluate transarterial chemoembolization TACE in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.
The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein AFP and find out what effects, if any, they have in subjects with liver cancer. This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI Durvalumab in combination with tremelimumab, MEDI monotherapy or tremelimumab monotherapy in subjects with unresectable hepatocellular carcinoma.
This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression after receiving at least 1 line of therapy. Patients will receive futibatinib 20 mg daily Days and will receive pembrolizumab mg Day 1 of each 21 day cycle per current clinical standard of care. The objective of the program is to provide access to TAS to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS and in whom therapy with TAS is clinically indicated.
The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.
Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States 1. Colorectal cancer arises from colonic polyps. The major types of polyps associated with colorectal cancer development are adenomatous tubular which is most common and other types are villous and tubulovillous and serrated hyperplastic, sessile or traditional polyps with varying degrees of dysplasia 2. Hyperplastic polyps are common but they have a low malignancy potential 3.
There is evidence that colonic inflammation plays a major role in colon polyp and colorectal cancer development. For example, inflammatory bowel disease is a major This is a phase II trial that will study how well tucatinib ONT and trastuzumab work in treating patients with colorectal cancer with a specific genetic marker human epidermal growth factor receptor 2 - HER2 that has spread to other places in the body or has come back and cannot be removed by surgery.
Tucatinib has been found to specifically target and inhibit HER2. To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer CRC after curative resection of liver metastasis and completion of all planned chemotherapy.
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer CRC , and consists of Part A dose regimen finding , followed by Part B dose expansion. Part B dose expansion will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. The purpose of this study is to see how the DNA methylation a biochemical process involved in cell development is activated during initial tumor growth and tumor progression.
In order to look at this in patients with colorectal cancer or adenoma we must look at their tissue collected during surgery. Fresh tissue is required in order to study the primary cells in culture. This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
The objectives of this study are to genomically characterize patient-derived organoids PDOs and primary tissues from colorectal peritoneal cancer CRC disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.
The purpose of this study is to show the quality of life and bowel function in patients who have been diagnosed with rectal cancer and are known to have Hereditary Nonpolyposis Colorectal Cancer HNPCC , especially to make comparisons between clinical managements, family history, and health behaviors.
This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
The purpose of this study is to determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma. The purpose of this study is to evaluate the safety and clinical activity of the combination of durvalumab with CV in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer CRC or gastric cancer to study the safety and tolerability of SC and consists of Part A dose regimen finding in participants with CRC followed by Part A in participants with gastric cancer.
Part B dose expansion will enroll participants into separate disease specific cohorts of CRC or gastric cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT in combination with a fixed dose of avelumab to determine the maximum tolerated dose MTD of eFT and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT at the recommended dose in combination with avelumab or eFT monotherapy.
Parts 1 and 2 will also evaluate pharmacokinetics PK and pharmacodynamics. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme. The primary purpose of this study is to confirm the specificity of a multi-target stool DNA test, Cologuard, in an average risk population, ages The purpose of this study is to evaluate the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy CIPN induced by the drug oxaliplatin.
The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event.
The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.
The purpose of this study is to determine the performance of the Exact IBD-ACRN inflammatory bowel disease-advanced colorectal neoplasia surveillance test to detect colorectal cancer CRC and colorectal neoplasia in patients with inflammatory bowel disease.
Enrolled subjects must have undergone colonoscopy no more than 90 days prior to enrollment, will collect a stool sample for the surveillance test and then must undergo colonoscopy or surgical intervention within days after enrollment.
The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. This study is to define the safety profile and to determine the maximum tolerated dose MTD and preliminary efficacy of AbGn administered every 28 days 4 weeks in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal or pancreatic adenocarcinoma.
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis.
The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks. The purpose of this study is to form processes to get findings from targeted gene sequencing that can be acted on using two common actionable genetic disorders—familial hyperlipidemia and familial colorectal cancer.
The purpose of this study is to determine the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness peripheral neuropathy caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer.
Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy. Drugs used in chemotherapy, such as liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C and GRT-R, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.
This phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.
This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, Lu-DOTA0-Tyr3-Octreotate Lutathera , prior to its commercial availability. The purpose of this registry at Mayo Clinic Jacksonville, is to keep a database and biospecimens of all patients treated surgically and non-surgically for a gastro-enteropancreatic mass or a suspected metastatic lesion from a gastro-entero-pancreatic primary.
This registry will keep demographic, clinical and pathologic data on each patient as well as follow-up information on outcome endpoints such as death and recurrence of disease, blood cell samples, and tissue samples from surgically removed tumors. The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C and GRT-R, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors. The purpose of this study is to determine the recommended Phase 2 dose RP2D of TBio when administered by direct injection into tumor s alone and when combined with pembrolizumab in patients with solid tumors RIVAL The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer.
Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer.
This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery.
It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.
The purpose for this study is to find out if MEDI and durvalumab will work and be safe for the treatment of solid tumors. This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 T cell immunoglobulin and mucin containing protein-3 antibody TSR, as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have limited available treatment options.
The study will be conducted in 2 parts: dose escalation and cohort expansion. The study will be divided into 2 parts Part 1 and 2. Part 1 is a dose-escalation assessment to evaluate the safety and tolerability of the DNA methyltransferase inhibitor azacitidine in combination with the programmed death receptor-1 PD-1 inhibitor pembrolizumab and the indoleamine 2,3-dioxygenase IDO-1 inhibitor epacadostat.
Once the recommended doses have been determined, subjects with previously treated NSCLC and microsatellite-stable colorectal cancer CRC will be enrolled into expansion cohorts in Part 2.
The primary purpose of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development. The ultimate goal of this biobank will be to provide the resource to initiate an exploration of human saliva as a potential liquid biopsy for cancer detection and surveillance.
THe purpose of this study is to examine the current and potential future therapeutic relevance of pharmacogenomics PGx testing for a cohort of cancer patients in order to improve quality of life QOL in patients receiving clinical care at Mayo Clinic. The purpose of this study is to evaluate the tolerability and safety profile of ASP when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced unresectable or metastatic solid tumors and to characterize the pharmacokinetic profile of ASP when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose RP2D of ASP when administered as a single agent and in combination with nivolumab or pembrolizumab.
This study will also evaluate the antitumor effect of ASP when administered as a single agent and in This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery.
Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.
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Additional inclusion criteria for patients included in part Arm D:. Patients with expected overall survival of months without a liver transplant. The patient might be included without further chemotherapy treatment. Patients may have resectable pulmonary lesions at time of inclusion in the present study. Try the modernized ClinicalTrials. Learn more about the modernization effort.
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