Clinical Research Directory

Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.

Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer

This study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). The primary endpoint of this study is the 1-year local control rate (LCR).

Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer

This is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed). However, not all types of PDACs are resectable, especially if they are close to important structures like blood vessels or intestines. These types of PDACs are treated with chemotherapy such as FOLFIRINOX. Research studies showed that chemotherapy after surgical resection of PDAC tumors reduced the risk of the cancer returning. Chemotherapy is used to treat PDAC that has not spread outside of the pancreas and is not resectable. FOLFIRINOX is a chemotherapy treatment that combines multiple chemotherapeutic agents, including oxaliplatin, leucovorin, irinotecan, and 5-FU. Patients receive these agents by intravenous infusion. Of these drugs, 5-FU requires you to return home with a chemotherapy pump that will deliver chemotherapy over 46 hours. This regimen has been studied in pancreatic cancer that has been removed with surgery as a method for preventing the cancer from returning. Studies showed FOLFIRINOX chemotherapy reduced the risk of cancer returning and increased patients survival. In this study, researchers want to know if FOLFIRINOX chemotherapy given before surgery will make the cancer easier to remove with surgery and increase the chances of the cancer staying away after surgery. Researchers have shown that pancreatic cancers are not all the same when you look at the DNA and RNA that is inside a pancreatic cancer cell. Depending on the expression of different genes in a cancer cell, some pancreatic cancers may respond differently to chemotherapy. In this study researchers want to know if FOLFIRINOX chemotherapy can change the genetic profile of the cancer. This will be studied by obtaining a biopsy of the cancer before the start of chemotherapy, and after 8 treatments of chemotherapy. They will also study cancer cells that will be collected from blood samples.

Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Cancer

This study is a single-center, observational clinical trial designed to enroll a total of 70 pancreatic cancer patients. Tumor tissue sections from 60 patients will be retrospectively collected to establish a treatment response prediction model using spatial transcriptomics and other analyses. Fresh tumor tissue and blood samples from 10 patients will be prospectively collected to establish pancreatic cancer organoids and humanized immunocompetent mouse models for functional validation and exploration of the underlying molecular mechanisms.

Tunlametinib + AG + Cetuximab β as First-Line Therapy for Advanced Pancreatic Cancer

This study is a prospective, open-label, single-arm clinical trial evaluating the safety and efficacy of tunlametinib in combination with gemcitabine/albumin-bound paclitaxel and an EGFR monoclonal antibody as first-line therapy in treatment-naive subjects with advanced pancreatic cancer.

Pancreatic Cancer Detection Consortium

This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.

Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

This project aims to establish a single-center, prospective, observational clinical cohort for pancreatic cancer immunotherapy. It plans to enroll 100 patients with advanced pancreatic cancer, collecting tumor tissue sections, plasma, serum, and fecal samples. Through multi-omics analysis including proteomics, metabolomics, and microbiomics, the project will develop predictive models for immunotherapy response.

Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents

The goal of this randomized controlled trial is to compare uncovered, partially covered, and fully covered self-expandable metal stents (SEMS) in the palliative treatment of distal malignant biliary obstruction in a Swedish multicenter study. The main questions it aims to answer is: Is the stent patency rate different depending of stent type? Is the stent patency time different depending of stent type? Is the patient survival different between the groups? Which complications are seen, and do they differ between the groups? Are there different mechanisms behind the stent failure depending on stent type? Patients will at ERCP, with a guidewire passed through the stenosis in the bile duct, be allocated to either uncovered, partially covered, and fully covered (SEMS). Totally, 450 patients will be recruited, 150 in each study arm, according to the power analysis. Patients will be followed in a monthly surveillance by a study nurse up to 12 months after stent insertion. Endpoints are: alive after 12 months with a patent stent, death with a patent stent, stent dysfunction with a subsequent intervention i.e. repeated ERCP or PTC = "objective stent failure", stent dysfunction, jaundice or cholangitis, but not intervention has been undertaken due to a poor condition of the patient, "clinical stent failure", the patient has undergone curative surgery or a bilio-enteric by-pass (a gastro-enteroanastomosis or a duodenal stent is not a reason for exclusion), the patient refuses further follow-up.

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.

Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer

Many patients with advanced pancreatic cancer and colorectal cancer experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called "symptom burden") can negatively affect a patient's quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival. Current approaches to manage these cancer-associated symptoms often work poorly, with most patients reporting a moderate to severe symptom burden. Therefore, there is an urgent need for treatments that improve these symptoms in patients with advanced pancreatic and colorectal cancer, and data suggests that medical cannabis can help. In this research study, we are examining the usefulness of using medical cannabis in patients with advanced pancreatic cancer and colorectal cancer to further study how cannabis can impact their symptom burden.

Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer

Autologous T-cells engineered to express CARs targeting Mesothelin and Claudin18.2, for Unresectable locally advanced or metastatic pancreatic adenocarcinoma (Pancreatic Ductal Adenocarcinoma, PDAC), administered as two separate sequential infusions following lymphodepleting chemotherapy

Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-

The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.

Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.

Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.

The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.

Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.

mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Modified FOLFIRINOX (mFOLFIRINOX) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. While radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. Stereotactic body radiotherapy (SBRT) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. This trial aims to compare the efficacy and safety of mFOLFIRINOX with or without SBRT in patients with locally advanced pancreatic adenocarcinoma

A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer

This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of second-line systemic chemotherapy sequential NKG2D CAR-NK cell therapy for pancreatic cancer

Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer

This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.

Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography

Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct. ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These complications are related to patient characteristics, experience of the endoscopist performing the procedure, and specific factors to the technique. Due to its complexity, quality assurance, operator training and auditing are required to increase success and minimize complications. There are quality indicators suggested by the main scientific societies in relation to technical aspects and complications, recommending their monitoring and auditing. Most endoscopy units lack records to monitor quality and complications, which prevents the assessment of quality and the identification of areas for improvement. Given the lack of evidence of the quality of ERCP in the Spanish population, the investigators will be conducting a multicenter, national prospective study that will include subjects who undergo ERCP. Patient data and technical aspects of the procedure will be recorded and all included patients will be monitored to identify complications. The quality indicators obtained within the registry will be compared with those established by scientific societies and the relationship between complications and technical factors will be analyzed.

Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer

This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.

Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer

To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer

Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer

The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.

Upfront EUS CGN/CPN vs Conventional Step up Approach for Inoperable Painful Pancreatic Cancer

Patients with unresectable pancreatic cancer are often demoralized by intractable, persistent and incapacitating pain. It must be managed aggressively and strong opioids are recommended as the mainstay of treatment. However, patients develop opioid-related adverse effects. EUS-guided celiac plexus neurolysis (CPN) and celiac ganglion neurolysis (CGN) has been shown to provide high efficacy for pain control. The optimal timing, however, is in debate.

PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT

The study consists of a 25 ml blood sample collection: * Before the start of treatment * Approximately 2 months after the start of induction chemotherapy * At the end of induction chemotherapy * Prior to local treatment (radiotherapy, surgery) * At the time of tumor progression Collection of tumor material: * During the initial diagnostic biopsy * On the operating room in case of surgery * At tumor biopsy in case of recurrence or progression (optional) As well as the completion of a questionnaire at inclusion.