Clinical Trials

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It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice.  We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.

Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers (MK-3475 GI)

Study Name: Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers (MK-3475 GI) ClinicalTrials.gov Identifier (if applicable): NCT02268825 Institution Name: Huntsman Cancer Institute Institution Address: 2000 Circle of Hope, Salt Lake City, UT, 84112 Website: http://healthcare.utah.edu/huntsmancancerinstitute/clinical-trials/ Principal Investigator: Sunil Sharma, MD, (801)581-4477, sunil.sharma@hci.utah.edu Study Coordinator: Rachel Kingsford, (801)585-0115, rachel.kingsford@hci.utah.edu Overview: This is a trial to assess MK-3475 in combination with mFOLFOX6 followed by a Phase II open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal and biliary carcinoma) to assess response rate, clinical benefit rate and survival Enrollment: 128 Study Start Date: 1/23/15 Estimated Completion Date: 1/23/17 Purpose of the Study – in Layman’s Terms: Response Rate|Clinical... read more

Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma

Study Name: NRG-GI001: Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma Institution Name: NRG Oncology, Massachusetts Principal Investigator: Ted Hong, (617) 724-1159, TSHONG1@mgh.harvard.edu Additional Principal Investigators: Theodore Hong, MD Massachusetts General Hospital 100 Blossom Street, Boston, MA 00214, 617-724-1159/Fax: 617-726-3603 TSHONG1@mgh.harvard.edu Laura A. Dawson, MD, Princess Margaret Cancer Centre University of Toronto, 610 University Avenue, Toronto, ON, Canada MSG 2M9, 416-946-2125/Fax: 416-946-6566, Laura.dawson@rmp.uhn.on.ca Study Coordinator: Ted Hong Study Coordinator Phone: (617) 724-1159 Study Coordinator Email: TSHONG1@mgh.harvard.edu Overview: To evaluate the addition of liver-directed radiation therapy to chemotherapy with respect to overall survival (OS) for patients with unresectable, localized intrahepatic cholangiocarcinoma Enrollment: 182 Study Start Date: 11/25/14 Estimated Completion Date: 6/26/19 Purpose of the Study – in Layman’s Terms: To... read more

A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma

Study Name: A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma ClinicalTrials.gov Identifier (if applicable): NCT02256982 Institution Name: Massachusetts General Hospital Institution Address: 55 Fruit Street, Boston, Massachusetts 02114 Principal Investigator: Ted Hong, MD, (617)724-4000, tshong1@partners.org Study Coordinator: Tarin Grillo, (617)724-3661, tgrillo@partners.org Overview: This study is to assess the possibility of using radiation therapy to treat intrahepatic cholangiocarcinoma. The study interventions involved this trial may include one or more of the following: Chemotherapy (Gemcitabine and Cisplatin), Surgical Resection and Lymphadenectomy and or Radiation Therapy. Enrollment: 48 Study Start Date: 10/31/14 Estimated Completion Date: 8/31/20 Purpose of the Study – in Layman’s Terms: This study is to assess the possibility of using radiation therapy to treat... read more

Study of Low-Dose Radiation Therapy to the Whole Liver in Combination with Gemcitabine and Cisplatin in Intrahepatic Cholangiocarcinoma

STUDY NAME: Study of Low-Dose Radiation Therapy to the Whole Liver in Combination with Gemcitabine and Cisplatin in Intrahepatic Cholangiocarcinoma ClinicalTrials.gov Identifier: NCT02254681 STUDY CENTER: Virginia Piper Cancer Institute 800 East 28th Street, Suite 602 Minneapolis, MN 55407 Phone: 612-863-7553 STUDY CONTACTS: Principal Investigator: Srinevas K. Reddy, MD PI Phone: 612-863-7553 PI E-Mail: srinevas.reddy@allina.com Study Coordinator: Laura Rockwell, RN Study Coordinator Phone: 612-863-9466 Study Coordinator E-mail: laura.rockwell@allina.com OVERVIEW: In this Phase II study, researchers want to determine whether lower dose radiation therapy improves the response derived from chemotherapy for intrahepatic cholangiocarcinoma by combining chemotherapy treatment with low dose radiation therapy to the entire liver and adjacent lymph nodes. Patients with surgically treatable or untreatable disease, and those with disease confined to or outside the... read more

PrE0204 – A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients with Advanced or Metastatic Cholangiocarcinoma (CCA)

STUDY NAME: PrE0204 – A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients with Advanced or Metastatic Cholangiocarcinoma (CCA) ClinicalTrials.gov Identifier: NCT02181634 STUDY CENTERS: A total of 20 US centers will participate. Please see ClinicalTrials.gov as sites are added. United States, Colorado Colorado Cancer Research Program Denver, Colorado, United States, 80222 Contact: Patty Gibson 303-777-2663 pgibson@co-cancerresearch.org United States, Iowa Siouxland Hematology-Oncology Associates Sioux City, Iowa, United States, 51101 Contact: Laura Martin 712-252-9329 martinl@shoa-research.org Contact: Patty Skorey-Solberg 712-252-9358 solbe United States, Louisiana Ochsner Medical Center New Orleans, Louisiana, United States, 70121 Contact: Socea May 504-842-2373 smay@ochsner.org Contact: Shana Lennard 504-842-4498 slennard@ochsner.org United States, Massachusetts University Massachusetts Memorial Medical Center Worcester, Massachusetts, United States, 01655 Contact: Courtney Coughlin... read more

ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

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