Clinical Research Directory

Predictive Value of Transcriptome-based OncoTreat/Oncotarget and Organoid Testing in Metastatic Pancreatic Cancer.

Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX, modified FOLFIRINOX or Gemcitabine-Abraxane. For subjects with a poor PS, instead, guidelines recommend single-agent infusions (e.g. Gemcitabine, Capecitabine or 5-FU alone). Nevertheless, upon disease progression therapeutic options are still scarce and with limited sustained efficacy. Overall survival in metastatic pancreatic cancer ranges between 9.1 and 13.5 months, while progression-free survival under either FOLFIRINOX or Gemcitabine-Abraxane spans between 5.5 and 6.4 months. This timespan reduces even further when standard second-line regimens must be initiated upon disease progression. Nowadays, genomic and transcriptomic analysis are crucial tools in cancer research that enable the identification of genetic mutations and alterations that drive the development and progression of cancer. By studying the changes in the DNA and RNA sequences of cancer cells, researchers can gain insights into the underlying molecular mechanisms of cancer and identify potential therapeutic targets. Genomic analysis can identify specific mutations or alterations that are present in cancer cells, while transcriptomic analysis can reveal changes in gene expression that may be linked to disease progression or response to treatment. These analyses are an essential component for the development of precision medicine approaches, which aim to tailor cancer treatment to the individual genetic profile of each patient. PDOs can replicate in vitro the biological, genetic and molecular aspects of the primary tumour. Some of their advantages include their rapid growth compared to xenografts, the possibility to perform high-throughput drug screening, and their direct application to precision oncology by predicting best therapies. In this study they will be used as an in vitro comparator of the molecular tests to the clinical course of the patient. Overall, combining genomic and transcriptomic analysis with PDO technology in cancer research might lead to exponential capacity to provide oncologic patients with extremely tailored and effective cancer treatments in the future. For HIPANC-002 these tests are being evaluated as non-interventional investigational IVD's. Test results are not to be used for protocol mandated therapy decisions.

PROMs After Pancreatectomy

The standard of care for a patient with resectable pancreatic is to perform pancreatic resection which, even in the modern era is associated with significant complications and impact on quality of life, often in the setting of poor survival even in the best scenario. Currently, there is a lack of data on patient quality of life after such procedures, how quality of life changes throughout the course of care, and whether patients who undergo these procedures are satisfied with their decision. This research is aimed to understand the impact of pancreatic surgery on patients' quality of life, how that impact changes over time, and patient satisfaction (or regret) with their decisions. This work will help improve the pre-operative conversation to help patients decide whether undergoing a pancreatic resection aligns with their post-operative goals of care.

Antecolic Versus Retrocolic Gastrojejunostomy During Whipple's Procedure

Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy. Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded. Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.

Robotic vs Open Pancreatoduodenectomy

Pancreatic surgery, specifically pancreatoduodenectomy (PD), is a complex procedure often required for patients with pancreatic or other periampullary cancers. In recent years, minimally invasive techniques have become more popular, especially robotic-assisted surgery. However, there are limited studies comparing robotic surgery to traditional open surgery. This is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess complications within 90 days after surgery. This study is important because it will provide evidence on which approach is safer and more effective for patients. The study follows a \*\*prospective, randomized, and multicenter design\*\*, meaning patients are assigned to either robotic or open surgery randomly, and multiple hospitals are involved. The study will include all eligible patients undergoing planned PD surgery, either by robotic or open technique. To be included in the study, patients must meet these conditions: * Be \*\*18 years or older\*\*. * Require \*\*planned PD surgery\*\*. * Sign an \*\*informed consent form\*\*. Who Cannot Participate? Patients will \*\*not\*\* be included if they: * \*\*Refuse the procedure\*\*. * Have \*\*uncertainty about vascular involvement\*\*. * Have a severe health condition classified as \*\*ASA IV\*\* (high-risk for surgery). The main outcome measured will be the \*\*Comprehensive Complication Index (CCI), a standardized way to assess post-surgical complications. Additional factors being studied include: * \*\*Clinical outcomes\*\* during and after surgery. * \*\*Quality of life\*\* assessments. * \*\*Surgical costs\*\*. * \*\*Hospital stay duration\*\*. * \*\*Need to switch from robotic to open surgery\*\*. * \*\*Need for additional surgery (reoperations)\*\*. * \*\*Hospital readmissions\*\*. Where Is the Study Being Conducted? The study is being conducted in \*\*ten major hospitals across Spain\*\*: 1. Hospital del Mar, Barcelona 2. Hospital Balmis, Alicante 3. Hospital Vall d'Hebron, Barcelona 4. Arnau de Vilanova, Lleida 5. Joan XXIII, Tarragona 6. Hospital Sant Pau, Barcelona 7. Germans Trias i Pujol, Barcelona 8. Hospital Clínic, Barcelona 9. HM Sanchinarro, Madrid 10. Hospital Rio Hortega, Valladolid How Long Will the Study Last? The study will take \*\*two years\*\* to complete, and patients will be followed for \*\*three years\*\* after surgery to track long-term outcomes. Why Is This Study Important for Patients? For patients undergoing PD, this study will provide essential information about the risks and benefits of robotic versus open surgery. The findings will help doctors determine the best surgical approach, leading to improved safety, faster recovery, and better long-term health outcomes. If you are a patient facing this type of surgery, participating in this study could contribute to valuable medical knowledge while ensuring that you receive a carefully monitored treatment plan.

DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer

The goal of this clinical trial is to estimate the antitumor response of mFOLFIRINOX + Dostarlimab + oral HD vitamin D3 in patients with non-pretreated histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas. The patients must have an Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 or 1 and adequate organ functions. The main objective of the study will be assessed by estimating Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease. The Secondary objectives are : * To assess the safety and tolerability of mFOLFIRINOX + Dostarlimab + HD Vitamin D according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by evaluating the Median Progression Free Survival (mPFS) in months, the Median Overall Survival (mOS) in months, the Median Duration of Response (mDOR) in months and Clinical benefit rate according to RECIST 1.1 (CBR) * To further evaluate the antitumor efficacy of mFOLFIRINOX + Dostarlimab + oral HD Vitamin D by evaluating the type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings There are also exploratory objectives to better understand the pancreatic adenocarcinoma. Participants will be cared for in the digestive oncology department. A selection review will be carried out to check compliance with the study eligibility criteria. Patients included in the study will be treated with 4 cycles of induction therapy. Each cycle lasts 6weeks and includes chemotherapy such as mFolfirinox D1,D15 and D29, combined with dostarlimab 500 mg every 3 weeks and daily oral vitamin D3. At the end of the induction treatment period, maintenance treatment will be instituted with LV5FU chemotherapy combined with dostarlimab 1000 mg every 6 weeks and daily oral vitamine D3. Treatment will be maintained until progression or unacceptable toxicity. Throughout this period, patients will be monitored for their safety. Imaging examinations will also be carried out to monitor the progression of tumour disease.