PDAC - Pancreatic Ductal Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

The ColoPan study evaluates the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer and pancreatic ductal adenocarcinoma patients. It combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids.

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

LASERBLOOD is based on a biophotonic technology that can be used to predict the development of Pancreatic Ductal Adenocarcinoma (PDAC) in particular categories of subjects at risk (e.g. persons with diabetes, obese people, patients with Intraductal Papillary Mucinous Neoplasm \[IPMN\] or other cystic diseases of the pancreas, etc.) and at the same time offer the possibility of verifying the real effectiveness of the treatments to which affected patients are subjected.

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.

The Canopy Cancer Collective Clinical Registry Protocol Non-Interventional Data and Sample Collection Registry Protocol Number of study sites 15 Study Design - Observational, registry Primary Objective To systematically collect and store comprehensive data on gastrointestinal cancer patients, encompassing both their past medical history and future clinical experiences, to address specific future research questions related to these malignancies, to establish and share best practices, and to support quality improvement initiatives focused on enhancing patient care and outcomes. Secondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory. 2\. Use real world data and patient reported outcomes to improve patient care throughout the treatment trajectory. Research Procedure(s) Collection of clinical and outcome data and cataloging and facilitating access to physical biological specimens and their associated data for future research purposes. Drugs/Devices used on Study None Study Population Patients with diagnosis of gastrointestinal (GI) cancers who seek care at one of the canopy centers and/or their affiliates Sample Size Up to 30000 patients in the prospective component Up to 70000 subjects will be enrolled on the retrospective component Study Duration for Individual Participants Anticipated to be at least 1 year Study Specific Abbreviations AE: Adverse Event CEC: Clinical Events Committee CT: Computed Tomography iCCA: Intrahepatic cholangiocarcinoma MRI: Magnetic Resonance Imaging OS: Overall Survival PFS: Progression Free Survival

The investigators are developing a non-invasive breath test to help us detect pancreatic cancer earlier. The test detects small molecules called volatile organic compounds that are made by pancreatic cancers. Pancreatic cancer is a rare disease but patients are often diagnosed at a late stage because their symptoms are the same as those of many common illnesses. This makes it hard for doctors to know which patients need to be tested for pancreatic cancer. If the investigators find pancreatic cancer at a late stage, it reduces the number of treatment choices for patients. Our test could be offered to patients who are experiencing vague symptoms, which might be caused either by pancreatic cancer or a common illness. This test could help doctors to identify which of those patients may have pancreatic cancer, and ensure they get referred for specialised pancreatic cancer tests. The investigators hope that this will allow us to diagnose pancreatic cancer earlier, increasing treatment choices for patients and improving survival from pancreatic cancer. The investigators have previously conducted a study (VAPOR1) which collected breath samples from people with and without pancreatic cancer. When the investigators analysed these samples, they found that there is a difference in the volatile organic compounds breathed out by people who have pancreatic cancer compared to those that do not. The investigators used these 'markers' to develop a breath test to diagnose pancreatic cancer. In VAPOR2, the investigators will study our breath test in a much larger group of patients who have been referred for further investigations for potential underlying pancreatic cancer to see how accurately it can pick up the small percentage of people who have pancreatic cancer.

Patients with early pancreatic cancer often have symptoms that could also be caused by many common benign conditions, or no symptoms at all. Jaundice, weight loss and pain are 'red flag' symptoms of pancreatic cancer that are linked to incurable disease. At the moment only patients with 'red flag' symptoms are urgently referred for diagnostic testing to find out if they have the cancer. As a result, late diagnosis is a common feature of pancreatic cancer. This leads to limited treatment options being available to patients by the time they are diagnosed, and ultimately results in poor survival rates. There is a clear need to improve earlier detection of pancreatic cancer so that patients with pancreatic cancer can be identified earlier and faster, enabling them to start treatment more quickly. The study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that may be altered by pancreatic cancers. For patients with non-specific symptoms, this test would help general practitioners (GPs) to identify those patients that may indeed have an underlying pancreatic cancer, who would benefit from referral for specialised pancreatic cancer tests.

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.

This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.

This study aims to refine and pilot test PDAC-PATHWAYS, a digital informational and supportive care app for patients who are initiating neoadjuvant therapy for pancreatic ductal adenocarcinoma (PDAC).

Pancreatic ductal adenocarcinoma (PDAC) has the poorest prognosis of all digestive cancers due to lack of early diagnosis and limited response to treatment. Patient-derived organoid technology has become a mainstay of precision oncology, enabling personalised functional characterisation of tumours (e.g. treatment evaluation and drug screening). Initial research carried out as part of the Cancer Profile project has produced the first organoids from resected PDAC parts. Only 15-20% of patients can benefit from surgical resection, which remains the only curative treatment. In contrast, most patients with PDAC undergo diagnostic fine-needle biopsies (FNB) using an echo-endoscopic procedure (EUS). The next step is therefore the reliable generation of organoids from limited quantities of biopsy material obtained by 'EUS-FNB'. The aim of the study presented here is to validate these organoids on the basis of the following characteristics: (i) morphological and proliferative characteristics, (ii) recapitulation of the genetic characteristics of the original tumour, (iii) expression of tumour markers.

This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.

The purpose of this study is to evaluate the safety and tolerability and overall survival (OS) of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on therapy.

This Phase III randomized trial, evaluates whether adding targeted radiation (SBRT) and an immunotherapy drug (Serplulimab) to standard chemotherapy (GnP) can extend the lives of patients with advanced pancreatic cancer.

The PANENCA trial aims to reduce postoperative complications in patients undergoing pancreatoduodenectomy (also known as a Whipple procedure), a complex surgical operation performed to remove tumors located in or near the head of the pancreas. One of the most frequent and serious complications after this surgery is postoperative pancreatic fistula (POPF), a leakage of pancreatic fluid from the surgical connection. POPF can lead to intra-abdominal infection, bleeding, and inflammation, often resulting in delayed recovery and postponement of subsequent oncological treatment. In severe cases, these complications may be life-threatening. Patients with a small main pancreatic duct (3 millimeters or less) are known to have a substantially higher risk of developing POPF. Previous studies have shown that several existing interventions may reduce the risk or severity of these complications. These include hydrocortisone, a medication that suppresses postoperative inflammation; octreotide, a medication that reduces the production of pancreatic secretions; and a surgical technique known as the ligamentum teres hepatis patch, which uses the patient's own tissue to protect nearby blood vessels in the event of a pancreatic leak. Because the development of pancreatic fistulas is multifactorial, the investigators hypothesize that a combined approach targeting different underlying mechanisms may provide a complementary and more effective protective effect than any single intervention alone. The PANENCA trial therefore evaluates whether the combined use of hydrocortisone, octreotide, and the ligamentum teres patch can reduce the rate of major postoperative complications after pancreatoduodenectomy. Patients participating in the study are randomly assigned to receive either the combination treatment in addition to standard perioperative care or standard perioperative care alone. The study medications are administered only during the first postoperative days, and the surgical patch is applied during the operation itself. No additional tests, monitoring procedures, or hospital visits are required beyond routine clinical care. This international, multicenter randomized trial includes patients at high risk for POPF who are undergoing pancreatoduodenectomy. The primary objective is to determine whether the combination treatment reduces the incidence of major postoperative complications. If proven effective, this bundle approach may be implemented more consistently across participating countries and incorporated into international clinical guidelines for pancreatic surgery.

This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer. This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors. After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.

Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with early diagnosis crucial for improving survival. Due to the absence of effective screening methods, most patients are diagnosed at advanced stages. The population undergoing low-dose computed tomography (LDCT) screening significantly overlaps with those at high risk for PDAC; however, traditional imaging methods have limited sensitivity for detecting pancreatic lesions. This study utilizes the Pancreatic Cancer Detection with Artificial Intelligence (PANDA) system to enhance LDCT for pancreatic cancer screening in a prospective, multicenter, observational cohort. PANDA will analyze LDCT images, followed by a multidisciplinary team (MDT) reassessment of abnormal interpretations. Based on MDT evaluation, individuals will be recalled for further examination, placed under a personalized follow-up plan, or monitored for at least one year. The primary outcomes include pancreatic cancer detection rate, positive predictive value, consensus rate, and recall rate, while secondary outcomes focus on early-stage cancers, resectable tumors, and safety indicators such as false positive rates and unnecessary procedures. This study aims to assess the effectiveness and safety of AI-assisted LDCT for PDAC detection, providing a practical solution for improving public health and enhancing early diagnostic capabilities.

The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment.