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Klatskin Tumor clinical trials

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NCT ID: NCT02232932 Active, not recruiting - Cholangiocarcinoma Clinical Trials

Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma

TRANSPHIL
Start date: March 2014
Phase: N/A
Study type: Interventional

A prospective, open-label, randomised, multicentre, comparative study in two parallel groups comparing an interventional group with liver transplantation preceded by neoadjuvant radio-chemotherapy and a control group receiving conventional liver and bile duct resection. The primary endpoint will be overall survival at 5 years in the intent-to-treat population. The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the intent-to-treat population. The number of subjects necessary is 54 patients (27 x 2): this population will enable the demonstration of a significant difference is 5-year survival rates between the transplanted group and the resected group with a power of 80% and a first-species risk of 5%, under the hypothesis that these survival rates are 70% in the transplanted group and 30% in the resected group.

NCT ID: NCT02166970 Completed - Klatskin Tumor Clinical Trials

Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

NCT ID: NCT02108145 Recruiting - Clinical trials for Hilar Cholangiocarcinoma

Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was presented in the area of the biliary duct bifurcation. Recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival. However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to the absence of randomized controlled trials.

NCT ID: NCT02082522 Terminated - Clinical trials for Hilar Cholangiocarcinoma

Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Start date: November 12, 2014
Phase: Phase 3
Study type: Interventional

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction. This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.

NCT ID: NCT02042443 Active, not recruiting - Clinical trials for Advanced Adult Hepatocellular Carcinoma

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

Start date: February 2014
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.

NCT ID: NCT01825603 Completed - Clinical trials for Pancreatic Adenocarcinoma

ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer

Start date: April 9, 2013
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other parts of the body (metastatic) and cannot be removed by surgery. ADH-1 may stop the growth of cancer cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ADH-1 together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

NCT ID: NCT01715402 Enrolling by invitation - Clinical trials for Hepatocellular Carcinoma

Optimization of Health Expenditure in Liver Surgery

Start date: September 2012
Phase: N/A
Study type: Observational

The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.

NCT ID: NCT00630890 Terminated - Cholangiocarcinoma Clinical Trials

Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)

Start date: October 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety of giving external beam radiation, followed by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is not amenable for surgical removal, are eligible. The hypothesis is that highly focused high dose radiation delivered using Cyberknife in conjunction with traditional radiation and chemotherapy can improve outcome in this patient population.

NCT ID: NCT00604266 Withdrawn - Cholangiocarcinoma Clinical Trials

Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study

PET/MRCP
Start date: August 2007
Phase: N/A
Study type: Observational

To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of potentially respectable hilar cholangiocarcinoma.