Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract...
Trace Element DeficiencyThe aim of the study is to determine the total concentration of selected trace elements (Cu, Zn, Fe), the proportion of free Cu and Cu bound to ceruloplasmin and the isotopic ratio of Cu65/Cu63 in blood serum samples from healthy volunteers and cancer patients using inductively coupled plasma mass spectrometry-based methods. The results will be statistically evaluated and the potential applications of the analytical methods used in cancer diagnosis and therapy will be assessed.
Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and...
Pancreatic CancerBiliary Tract Cancer1 moreIn patients with cancer, resistance training appears to be a safe and effective exercise modality to increase both lean muscle mass and strength, as well as attenuates cancer-related fatigue. It may serve as a feasible intervention in these patients to mitigate cachexia, especially if implemented before the onset of cancer cachexia or in a pre-cachectic state. This study is a multicenter randomized controlled trial that will compare a metabolic-stress induced resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic and biliary tract cancer, versus usual care on skeletal muscle and other health-related outcomes.
Molecular Profiling of Advanced Biliary Tract Cancers
Biliary Tract CancerBiliary tract cancer (BTC) accounts for <1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope...
Biliary DiseasePancreatic Disease4 moreThe purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.
Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract...
Adenocarcinoma MetastaticBiliary Tract Cancer5 moreAIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated...
Advanced Solid TumorsTriple Negative Breast Cancer6 moreThe purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Bladder CancerBiliary Tract Cancer5 moreThis is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.
Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic...
ThyroidRenal Cell Carcinoma17 moreA multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary...
Advanced Biliary Tract CancerThis is open-label, phase II study enrolling advanced BTC patients who have failed to 1st-line chemotherapy.
Tislelizumab(Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable,...
Biliary Tract CancerPD-1 Antibody2 moreThe aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC.