Cholangiocarcinoma

Researchers are evaluating two types of 12-mm self-expandable metallic stents for treating adults with unresectable malignant distal biliary obstruction, a condition caused by cancers such as pancreatic cancer and cholangiocarcinoma. This clinical trial aims to compare the effectiveness and safety of partially covered versus bare metallic stents, as it is unclear which stent type better prevents recurrent biliary blockage and reduces complications. The study is prospective, randomized, and single-center, focusing on patients who have already undergone percutaneous transhepatic biliary drainage PTBD. Participants will be randomly assigned to receive either a 12-mm partially covered or a 12-mm bare metallic stent, both placed through the existing PTBD tract using a percutaneous transhepatic approach. The stent placement will be followed by careful monitoring. The trial includes two groups one receiving the partially covered stent ComVi Biliary Stent and the other the bare stent Niti-S Biliary Uncovered Stent. The study will follow participants for 12 months after stent placement, with assessments at 3, 6, and 12 months. Throughout the study, participants will undergo evaluations to measure the cumulative incidence of recurrent biliary obstruction, stent patency duration, reintervention rates, overall survival, and procedure-related complications such as pancreatitis, cholecystitis, bleeding, perforation, and cholangitis. These assessments involve imaging and clinical follow-up visits. The outcomes will help guide the choice of the most suitable 12-mm metallic stent for patients with this condition, supporting better treatment decisions over a one-year period.

Researchers are evaluating a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-74 PET scans to the standard 18F-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytomaparaganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute NCI. Participants will receive an intravenous dose of 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline 18FFAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Biliary tract carcinoma BTC includes cancers of the gallbladder, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma. It is a highly aggressive cancer with poor outcomes, ranking sixth in gastrointestinal cancer incidence and tenth in cancer-related deaths worldwide. Because early symptoms are often absent and the disease tends to recur and spread, only about 16.5% of patients can have curative surgery, and the overall 5-year survival rate is under 5%. Early and accurate detection is crucial to improve patient outcomes. This research aims to assess the use of cell-free DNA cfDNA methylation in blood as a liquid biopsy for diagnosing and managing BTC. The study involves several groups, including healthy individuals, patients with confirmed benign biliary lesions, other gastrointestinal cancers, and those with confirmed or suspected BTC. Researchers will analyze methylation patterns in circulating tumor DNA ctDNA, a small fraction of cfDNA that carries tumor genetic and epigenetic information. This approach is studied for its potential to detect BTC early, assist in differential diagnosis, monitor prognosis, and guide therapy. Different cohorts serve as internal training, validation sets, and independent validation groups. Participants will provide blood samples and undergo clinical evaluations to measure the accuracy of the ctDNA methylation test in diagnosing BTC. The study will assess diagnostic performance by cancer subtype and stage, and ability to distinguish BTC from other conditions. Vital signs, organ function, and other health markers will be monitored to ensure participant safety. The study welcomes adults aged 18 to 80 years, with follow-up and assessments continuing until May 2026 to evaluate the tests clinical utility.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

Researchers are evaluating the safety, tolerability, and efficacy of intravenous HNF4 srRNA treatment in adults with advanced intrahepatic cholangiocarcinoma ICC, a type of liver cancer. This early phase 1, single-arm, open-label pilot study aims to assess how well patients tolerate the treatment and its effects on tumor response and survival. The study also explores the impact of the drug on tumor biomarkers and patient-reported outcomes over an average period of two years. Participants will receive HNF4 srRNA intravenously through a peripheral vein. The dosing schedule includes a second dose about 14 days after the initial treatment, followed by subsequent doses approximately every 28 days. Dose adjustments may be made based on patient tolerance and response. This dose escalation study tests increasing doses of 25, 50, and 100 micrograms. After at least four treatment cycles, some patients with stable or progressive disease may continue treatment combined with immunotherapy, targeted therapy, or chemotherapy, with doses adjusted as needed. During the study, participants will be closely monitored for safety and tolerability during a 14-day observation after the first dose. Researchers will regularly assess tumor response using RECIST v1.1 criteria and collect data on progression-free survival, overall survival, and quality of life through patient-reported outcomes. Laboratory tests, tumor biomarker analysis, and clinical evaluations will occur throughout the treatment and follow-up period lasting up to two years. The study aims to provide detailed information on treatment effects and participant experiences over time.

Researchers are studying the use of C-13-60 cells, a type of chimeric antigen receptor T cell therapy CAR-T, for treating patients with advanced malignant solid tumors that test positive for carcinoembryonic antigen CEA. This phase I, single-arm, open-label trial aims to assess the safety, tolerability, and how the drug behaves in the body, while also making early observations on its effectiveness. The study focuses on finding the appropriate dose for future phase II trials in various cancers including colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, and bile duct cancers. Participants will receive intravenous infusions of CEA-targeted CAR-T cells, with doses increasing stepwise from 2 to 10 million cells per kilogram of body weight. Before the cell infusion, patients undergo conditioning chemotherapy with Fludarabine and Cyclophosphamide to prepare the body. The dose escalation follows strict safety rules groups of patients receive increasing doses, and if severe toxicity occurs, the treatment is adjusted or stopped based on safety committee decisions. The trial includes a 28-day period of monitoring for dose-limiting toxicities after each infusion. Throughout the study, participants will have regular evaluations including tumor assessments, laboratory tests, and monitoring of cell levels in the blood. Researchers will track safety outcomes such as dose-limiting toxicities and maximum tolerated dose within one month. They will also measure disease control rates and various pharmacokinetic indicators over three months. The trial requires participants to agree to contraception use and undergo follow-up to evaluate treatment impact and safety. The overall study duration extends until the end of 2027, with detailed monitoring during and after treatment.

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.

Researchers are evaluating whether adding celecoxib to the standard treatment of pembrolizumab combined with gemcitabine and cisplatin can improve outcomes in patients with advanced intrahepatic cholangiocarcinoma who have high CK56 biomarker levels. This study is a randomized, open-label phase IbII trial aiming to identify more precise treatment strategies based on patient subgroups and biomarker status. Participants will be randomly assigned to either the control group receiving pembrolizumab with gemcitabine and cisplatin, or the experimental group receiving the same standard treatment plus oral celecoxib taken twice daily. Each treatment cycle lasts 21 days, with cisplatin administered for up to 8 cycles. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. Celecoxib starts one week before the first cycle and is taken continuously. During the study, participants will undergo regular imaging scans, lab tests, and safety evaluations to monitor tumor response and side effects. Blood and tissue samples will be collected to study tumor biology and biomarkers. The main outcomes measured include progression-free survival and objective response rate, along with safety. Researchers will manage any treatment-related adverse events, and monitoring continues until treatment ends or the disease progresses.

Gastrointestinal cancers cause significant health challenges worldwide due to the lack of effective and accessible early screening methods. Current diagnostic tools like endoscopy and imaging are invasive or not sensitive enough for early detection, leading to diagnoses at advanced stages with limited treatment options. Researchers aim to develop a noninvasive blood test using circulating microRNAs miRNAs that may help detect multiple types of gastrointestinal cancers early, improving possible outcomes. This study collects retrospective blood samples from participants with major gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, pancreatic ductal adenocarcinoma, esophageal squamous cell carcinoma, gastric cancer, and colorectal cancer, as well as from non-cancer controls. Small RNA sequencing will measure circulating miRNA levels. Using machine learning, investigators will identify a minimal panel of miRNAs that can distinguish cancer from non-cancer and differentiate among cancer types across diverse cohorts and geographic regions. Participants blood samples and clinical data will be analyzed to develop and validate this miRNA signature. The study evaluates the accuracy of the miRNA panel for cancer detection using measures like area under the receiver operating characteristic curve and sensitivity. This observational study uses existing samples and data and involves no active treatment. The research aims to create a scalable, cost-effective screening tool to support earlier diagnosis of gastrointestinal cancers.