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The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule DAVANAT is beneficial in treating advanced gall bladder and bile duct cancer.
Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with DAVANAT plus 5-Fluorouracil (DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive days of treatment followed by a 24-day follow-up period.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cancer of the Bile Duct
DAVANAT in combination with 5-Fluorouracil
Boston Medical Center
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:42:07-0400
This is a Phase II, multi-center study of a carbohydrate (DAVANAT) which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug co...
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In this study, investigators will investigate the microbiota of bile in common bile duct stone participants. Three key questions are of concern. The first one is whether there is bacteriri...
The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to t...
Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specifi...
Bile duct cancer is a highly aggressive malignancy wherein early diagnosis is difficult and few treatment options are available. MicroRNA-31 (miR-31) is reported to be related with survival in patient...
Bile duct cancer, although not among the most common tumors, still accounts for more and more worldwide deaths each year. By attempting to verify an overexpression of ALDOA in cholangiocarcinoma tissu...
Bile duct brushing (BDB) cytology, for the characterization of bile duct strictures, can be challenging to interpret when associated with a stent. Our study aims to identify the cytologic criteria for...
Detailed endoscopic findings of the bile duct mucosa have not been fully established. This fundamental ex vivo study assesses the relationship between magnified endoscopic findings and pathological fi...
Laparoscopic cholecystectomy is the standard surgical treatment for patients with benign gallbladder disease. However, bile duct injury continues to be reported as a surgical complication. Intraoperat...
Tumor or cancer of the COMMON BILE DUCT including the AMPULLA OF VATER and the SPHINCTER OF ODDI.
Adenocarcinoma of the common hepatic duct bifurcation. These tumors are generally small, sharply localized, and seldom metastasizing. G. Klatskin's original review of 13 cases was published in 1965. Once thought to be relatively uncommon, tumors of the bifurcation of the bile duct now appear to comprise more than one-half of all bile duct cancers. (From Holland et al., Cancer Medicine, 3d ed, p1457)
Tumors or cancer of the BILE DUCTS.
A congenital anatomic malformation of a bile duct, including cystic dilatation of the extrahepatic bile duct or the large intrahepatic bile duct. Classification is based on the site and type of dilatation. Type I is most common.
The largest bile duct. It is formed by the junction of the CYSTIC DUCT and the COMMON HEPATIC DUCT.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...