Clinical Research Directory

Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

This is a Phase 2 trial evaluating the combination of cemiplimab with the standard of care chemotherapy agent gemcitabine for the treatment of patients with metastatic pancreatic ductal adenocarcinoma with SWItch/Sucrose Non-Fermentable (SWI/SNF) alterations who have already been treated with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine/nab-paclitaxel chemotherapy.

Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma

This case-control study aims to evaluate the role of a polygenic risk score in predicting the risk of pancreatic ductal adenocarcinoma (PDAC). The study will compare genetic risk profiles between individuals with PDAC and controls without the disease in order to assess whether a polygenic risk score may help identify individuals at higher risk. The findings may contribute to improving risk stratification and supporting future strategies for early identification and prevention of pancreatic cancer.

Immunoparalysis After Pancreaticoduodenectomy

By 2030, pancreatic adenocarcinoma could become the second leading cause of cancer-related death in France. To date, Pancreaticoduodenectomy (PD) is the standard treatment for resectable adenocarcinoma of the pancreatic head. Despite advances in perioperative care, morbidity remains high, and the occurrence of postoperative complications can negatively impact patient's oncologic prognosis. Sepsis is the leading cause of postoperative death following PD and it remains mainly associated with the development of a clinically-relevant postoperative pancreatic fistula (CR-POPF). More recently, post-pancreatectomy acute pancreatitis (PPAP) has been defined as a very early complication after pancreatic resection. PPAP is an ischemic and inflammatory condition of the pancreatic remnant that may be responsible for nearly half of CR-POPFs. CR-PPAP can lead to sepsis with multiorgan failure and necrotizing pancreatitis, which are with CR-POPF the two main indications for reoperation and completion pancreatectomy. Despite the major impact of severe pancreatic complications on mortality after PD, no reliable early biomarker currently exists to predict their occurence. Immunoparalysis refers to the functional impairment of immune cells with monocytes showing altered capacity of cell presentation. In classical models of inflammation such as acute pancreatitis, sepsis and surgery, the initial systemic inflammatory response syndrome is simultaneously accompanied by a compensatory anti-inflammatory reaction, which may lead to immunoparalysis. mHLA-DR (Human Leukocyte Antigen-DR on Monocytes) is considered as the most appropriate biomarker to assess this immune dysfonction. Various studies emphasize the predictive value of mHLA-DR for early detection of adverse outcomes : in acute pancreatitis, mHLA-DR predicts the onset of severe forms as early as admission and after colorectal surgery, mHLA-DR enables earlier detection of anastomotic leakage compared to conventional biomarkers. The main hypothesis is that the severity of postoperative complications is driven by immunological factors. On one hand, this study seeks to improve the understanding of the relationship between the immune response after PD and the occurrence of pancreatic complications. On the other hand, it aims to assess if mHLA-DR could represent an early biomarker for detecting severe pancreatic complications. Therefore, the main objective of this study is to evaluate the association of mHLA-DR expression in the early postoperative period following PD and the occurrence of severe pancreatic complications

A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma

The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC. Participants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.

How Does Pre-operative Biliary Drainage in Pancreatic Adenocarcinoma Affect Surgical Outcomes in Pancreatic Cancer Surgery

Pre-operative biliary drainage (PBD) is a procedure used to relieve bile duct obstruction, a common issue in patients with pancreatic cancer. The obstruction occurs when a tumor blocks the bile duct, leading to jaundice and other complications. While PBD can help resolve jaundice and improve liver function, its impact on the overall outcomes of pancreatic cancer surgery is still debated. Recent research has focused on whether PBD before surgery improves patient outcomes, such as surgical success, recovery time, and long-term survival. Some studies suggest that draining the bile before surgery might reduce complications like infections, liver dysfunction, and jaundice-related risks. On the other hand, other research indicates that PBD could increase the chances of infection, delays in surgery, or complications from the procedure itself, such as bile leakage or inflammation. This study will look at patients undergoing pancreaticoduodenectomy to remove their head of pancreas pancreatic ductal adenocarcinoma over 8 years, and will compare the tumour characteristics of patients who have had PBD vs those who have not. Data will be gathered from the already available histological characteristics. No treatment would be affected and no tissue would be affected. This research study will focus on oncological characteristics such as tumour progression and lymphatic spread, with overall patient survival as secondary outcome measures.

OSCAR II STUDY - The ONCObind CTC Removal Study

This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in either mPDAC or mCRC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of mPDAC and mCRC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of either mPDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not candidates for chemotherapy or mCRC patients who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIR and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy with at least 5 cells/mL CTCs in peripheral blood and/or portal vein.