EUS-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. In the recent years fine needle biopsy (FNB) needles have largely replaced fine needle aspiration (FNA) for EUS-guided tissue acquisition. The Acquire FNB needle is a Franseen needle which has three symmetric cutting edges to obtain core tissue specimens. The Trident FNB needle has been recently introduced to the market for EUS-guided tissue acquisition. It has a multi-blade three-prong tip which one of the tips is longer than the other two.
The aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.
This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 candidate optimal dose of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in multiple Phase 2a proof-of-concept cohorts in malignancies of interest.
This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .
Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.
By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline resectable or resectable stage, and surgical resection remains the only curative option. However, total pancreatectomy (TP) often leads to severe diarrhea (incidence rate: 43.5%) due to exocrine insufficiency, and current pancreatic enzyme replacement therapy shows limited efficacy in some patients.
Recent studies highlight the critical role of gut microbiota in pancreatic cancer progression and postoperative recovery. Patients with pancreatic ductal adenocarcinoma (PDAC) exhibit a 1000-fold increase in intrapancreatic bacterial load compared to normal tissues, with significantly elevated Bacteroides abundance and reduced Firmicutes and Proteobacteria in fecal samples. Postoperative dysbiosis is linked to complications; for example, diarrhea after cholecystectomy is dominated by Proteobacteria, suggesting that microbial imbalance may underlie diarrhea following TP.
To address this, the study proposes fecal microbiota transplantation (FMT) via oral capsules. FMT has proven effective in treating recurrent Clostridium difficile infection by restoring healthy microbiota. This research will systematically evaluate the efficacy and safety of FMT in alleviating post-TP diarrhea through clinical indicators and 16S rDNA sequencing, offering novel insights into postoperative management of pancreatic cancer.
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
In this prospective study, new diagnostic tools will be explored for patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (BR or LAPDA) who undergo neoadjuvant chemotherapy with FOLFIRINOX. The diagnostic work-up and therapy for the study population will not differ from the gold standard during the study; only additional diagnostic tools will be implemented, and their value will be analyzed post hoc.
The 5-year survival rate of pancreatic cancer is 9%, but this can be drastically improved if surgery is possible. With its increasing incidence and poor prognosis, pancreatic cancer is becoming a global oncologic challenge where major breakthroughs are still required to improve patient outcomes. Patients with BR or LAPDA typically undergo neoadjuvant treatment with FOLFIRINOX chemotherapy, followed by referral for surgery if a response is observed. In these cases, surgical resectability is difficult to predict based on CT imaging due to the tumor's desmoplastic reaction, which obscures tumor-vessel contact without clear morphological changes. Consequently, patients without tumor progression on CT and with a decreased tumor marker (CA 19-9) are considered for surgical exploration to ensure that no potentially curative treatment is denied. However, the non-specific nature of CA 19-9 and the unreliable spatial changes on CT do not allow for accurate patient stratification. Therefore, alternative diagnostic strategies are needed to better predict resectability, minimizing unnecessary laparotomies while ensuring that potentially curative approaches are not overlooked.
In this project, the investigator will apply diffusion-weighted magnetic resonance imaging (DW-MRI), as it has been shown to be useful in assessing tumor response beyond morphological parameters. DW-MRI enables the detection of functional tumor changes, variations in vascularization, and fibrosis without modifications in shape. The statistical evaluation of visual information using radiomics optimizes data analysis, allowing comparisons over time (before and after chemotherapy) and correlation with operative findings (resectable or unresectable tumor).
The investigator will focus on patients with BR and LAPDA and assess whether a combination of clinical and genetic factors can predict successful surgical resection. To this end, DW-MRI imaging will be complemented by multi-omics profiling in liquid biopsies. Furthermore, the investigator aims to validate, in a prospective patient cohort, the predictive value of recently published single nucleotide polymorphisms (SNPs) in genes that regulate cancer progression, invasion, and metastasis. Some alleles of these SNPs have been associated with an increased risk of tumor-related mortality compared to protective genotypes.
The current trial will provide important data on the recurrence rates and patterns of failure using state of the art target agent, chemotherapy and proton beam technology for patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater would be considered evidence of a regimen potentially worthy of further study as a new treatment paradigm in one arm in a future phase III trial.
The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.
