Active clinical trials for "Biliary Tract Neoplasms"

BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.

The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing (and/or tissue biopsy) is challenging due to infection risk, technical impracticalities and resource limitations, such as during the COVID-19 pandemic and the subsequent recovery period.

Biliary tract cancer (BTC) compromises a heterogenous group of tumors with poor prognoses. Curative surgery remains the first choice for localized disease; however, most BTC patients had unresectable or metastatic disease. The gold standard therapy for these patients is chemotherapy with gemcitabine and cisplatin. There are no consensus guidelines for standard treatment in a second-line setting, although the data of the ABC-06 trial showed a slight survival benefit from oxaliplatin and 5-fluorouracil combination chemotherapy. Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

A pancreaticoduodenectomy is performed in patient with pancreatic cancer. The most common and serious complication is leakage between the intestine and the remnant pancreas after this procedure. It occurs in 20-30%. The result is often prolonged hospital and ICU stay, reoperations and deaths (3-5%). To detect a leakage early before the patient becomes seriously ill, thereby initiating treatment is therefore very important. By inserting a thin microdialysis catheter near the anastomosis between pancreas and intestine before closure of the abdominal wall, the investigators will analyze substances such as lactic acid, pyruvate, glycerol, etc. and if these substances may reveal anastomosis leakage at an early stage. Observational studies have shown that if a leakage occurs, glycerol concentration in the microdialysate will rise significant after few hours, and changes in lactic acid and pyruvate values will change as a sign of inflammation. The investigators want to conduct a randomized study comparing patients undergoing pancreaticoduodenectomy and using microdialysis in half of the included population.

A substantial proporation of patients with biliary tract malignancies still experience disease recurrence after curative resection. ctDNA-based minimal residual disease (MRD) method has been widely used to monitor postoperative recurrence in solid cancers, but few studies have been reported in biliary tract cancers. The present clinical trial aims to elucidate the correlation between the postoperative ctDNA status and the prognosis of patients with biliary tract cancers, and evaluate whether ctDNA could better predict patients' recurrence and guide clinical practice.

ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.

Patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass or lesion will have a tissue sample collected and stored for future research of liver and biliary diseases. A blood sample may also be collected at the time of enrollment.

Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.