Clinical Trials

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

Tapestry is a Mayo Clinic research study, which includes receiving genetic sequencing data from Helix, up to the full whole exome dataset. The goal of this study is to provide: (i) an immediate interpretation of ancestry/genealogy and several non-disease traits, as well as, clinically actionable variants for an inherited form of high cholesterol called familial hypercholesterolemia (FH), breast and ovarian cancer (HBOC), and Lynch syndrome to each participant; (ii) an additional subset of focused clinically actionable genetic findings, such as, certain types of hereditary cancers, hereditary heart conditions and severe responses to certain medications, will be returned to the provider and to the participant, via the provider, genetic counselor consultation, and/or Mayo Clinic research interpretation; (iii) storing of genomic and phenotypic data for future research analysis.

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gluten free diet (GFD) for at least one year prior to screening.

The primary purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.

The primary purpose of this study is to evaluate the effectiveness of the Minnesota Medical Technologies (MMT) anal insert device on fecal continence over 3 months in patients with fecal incontinence (FI).

The purpose of this study is to understand why patients with indigestion, with or without diabetes, have gastrointestinal symptoms and, in particular, to understand where the symptoms are related to increased sensitivity to nutrients.Subsequently, look at the effects of Ondansetron on these patients' symptoms.

In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that induced genetic variation with PARP inhibition disrupting the tumor microenvironment and increasing neoepitope expression can sensitize tumors to immune checkpoint inhibition. We have developed preliminary data with RNAseq suggesting that potent PARP inhibition is associated with gain of novel mutations in pancreas cell lines, even compared to cisplatin alone, or irinotecan alone. We propose that a combination of PARP inhibition and anti-PD1 therapy has valuable therapeutic potential in pancreatic cancer. HRR deficient pancreatic cancer has largely been defined to date based on mutations in well-established genes such as BRCA1/2 and PALB2. However, more DNA repair associated genes are becoming associated with risk for pancreatic cancer and may well impact tumor phenotype. The goal would be to evaluate the combination of niraparib and TSR-042 in patients with germline or somatic mutations in BRCA1/2 or PALB2.

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. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell free DNA and circulating tumor cells at baseline, after 3 and 6 cycles, and at progression. We will collect tumor biopsy specimens before treatment initiation to develop patient derived tumor organoid.

The purpose of this multicenter, prospective, single arm, non-randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.

This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE - Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. - Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required). - No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and are negative, then enrollment can be considered after review with the study PI). Potentially Resectable Pancreatic Cancer - No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (SMA) and, if present, replaced right hepatic artery. - No involvement or <180° interface between tumor and vessel wall of the portal vein and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence. - For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease. Borderline Resectable Pancreatic Cancer - Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible occlusion of the SMV-PV. - Tumor-vessel interface <180° of the circumference of the SMA. - Tumor-vessel interface <180° of the circumference of the celiac artery. - Reconstructible short-segment interface of any degree between tumor and hepatic artery.