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Active, not recruiting No phase listed Observational

Outcomes From Treatment Liver and Bile Duct Diseases

NCT04637243
Conditions
Benign or Malignant Liver and Bile Duct Disease
Interventions
Treatment of Benign or Malignant Liver and Bile Duct Diseases
Other
Lead sponsor
Methodist Health System
Other
Eligibility
18 Years and older
Enrollment
126 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Richardson, Texas
Conditions
Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Cancer, Advanced Solid Tumor, Cholangiocarcinoma, Bile Duct Cancer
Interventions
CF33-hNIS, Pembrolizumab, Modified FOLFOX
Biological · Drug
Lead sponsor
Imugene Limited
Industry
Eligibility
18 Years and older
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
10
States / cities
Tucson, Arizona • Springdale, Arkansas • Duarte, California + 7 more
Conditions
Liver Disease, Cholestasis, Cirrhosis, Pruritus, Itching
Interventions
Gabapentin, Placebo
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
18 Years to 80 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2004
U.S. locations
1
States / cities
New York, New York
Conditions
Hepatocellular Cancer, Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
Interventions
durvalumab, Doxorubicin-Eluting Beads, TACE, bevacizumab, Tremelimumab
Drug · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma, Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations
Interventions
FT-2102, Azacitidine, Nivolumab, Gemcitabine and Cisplatin
Drug · Biological
Lead sponsor
Forma Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
14
States / cities
Gilbert, Arizona • Aurora, Colorado • Miami, Florida + 10 more
Conditions
Biliary Tract Cancer
Interventions
Varlitinib, Capecitabine, Placebo (for Varlitinib)
Drug
Lead sponsor
ASLAN Pharmaceuticals
Other
Eligibility
Not listed
Enrollment
151 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
11
States / cities
Gilbert, Arizona • Detroit, Michigan • St Louis, Missouri + 8 more
Conditions
Cholangitis, Sclerosing, Liver Cirrhosis, Biliary
Interventions
budesonide
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
18 Years to 70 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 1999
U.S. locations
1
States / cities
Rochester, Minnesota
Conditions
Gallstones, Appendicitis, Pelvic Pain
Interventions
Endoscopic Cholecystectomy, Endoscopic Appendectomy, Endoscopic Peritoneoscopy
Procedure
Lead sponsor
St. Luke's-Roosevelt Hospital Center
Other
Eligibility
18 Years to 60 Years · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
1
States / cities
New York, New York
Conditions
Biliary Tract Cancer, Cholangiocarcinoma, Biliary Tract Neoplasms
Interventions
Tumor Infiltrating Lymphocytes (TIL)
Biological
Lead sponsor
Udai Kammula
Other
Eligibility
18 Years to 75 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2031
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Conditions
Extrahepatic Bile Duct Cancer, Nausea, Vomiting, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
Interventions
aprepitant, gemcitabine hydrochloride, capecitabine, fluorouracil, radiation therapy, questionnaire administration, quality-of-life assessment, nausea and vomiting therapy, management of therapy complications
Drug · Procedure · Other
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2012
U.S. locations
1
States / cities
Winston-Salem, North Carolina
Conditions
Choledocholithiasis, Bile Duct Diseases, Bile Duct Carcinoma
Interventions
"Air" contrast cholangiography using carbon dioxide gas
Other
Lead sponsor
University of Virginia
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2024
U.S. locations
1
States / cities
Charlottesville, Virginia
Conditions
Biliary Tract Neoplasms, Cholangiocarcinoma, Bile Duct Cancer, Liver Cancer, Gallbladder Cancer
Interventions
Pembrolizumab (MK-3475), Oxaliplatin, Capecitabine
Biological · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
Interventions
Trastuzumab deruxtecan
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 120 Years
Enrollment
477 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
12
States / cities
Duarte, California • Santa Rosa, California • Chicago, Illinois + 8 more
Conditions
Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Localized Unresectable Adult Primary Liver Cancer, Periampullary Adenocarcinoma, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
Interventions
cediranib maleate, oxaliplatin, leucovorin calcium, fluorouracil
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
7
States / cities
Cleveland, Ohio • Columbus, Ohio • Mayfield Heights, Ohio + 3 more
Conditions
Primary Sclerosing Cholangitis, Inflammatory Bowel Disease
Interventions
Vancomycin
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 80 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Minneapolis, Minnesota
Conditions
Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer, Localized Gastrointestinal Carcinoid Tumor, Localized Resectable Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Metastatic Gastrointestinal Carcinoid Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Primary Peritoneal Cavity Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Adult Soft Tissue Sarcoma, Recurrent Colon Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Small Intestine Cancer, Recurrent Uterine Sarcoma, Regional Gastrointestinal Carcinoid Tumor, Small Intestine Adenocarcinoma, Small Intestine Leiomyosarcoma, Small Intestine Lymphoma, Stage 0 Non-small Cell Lung Cancer, Stage I Adult Soft Tissue Sarcoma, Stage I Colon Cancer, Stage I Gastric Cancer, Stage I Non-small Cell Lung Cancer, Stage I Ovarian Epithelial Cancer, Stage I Ovarian Germ Cell Tumor, Stage I Pancreatic Cancer, Stage I Rectal Cancer, Stage I Uterine Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage II Colon Cancer, Stage II Gastric Cancer, Stage II Non-small Cell Lung Cancer, Stage II Ovarian Epithelial Cancer, Stage II Ovarian Germ Cell Tumor, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage II Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Uterine Sarcoma, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Adult Soft Tissue Sarcoma, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Uterine Sarcoma, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
Interventions
EF5, motexafin lutetium, pharmacological study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Malignant Solid Tumour, Biliary Cancer, Pancreatic Cancer
Interventions
Gemcitabine, Capecitabine, ZD6474
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
1
States / cities
Aurora, Colorado
Completed Phase 2 Interventional Results available

Pentoxifylline for Primary Biliary Cirrhosis

NCT01249092
Conditions
Primary Biliary Cirrhosis
Interventions
Pentoxifylline
Drug
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years to 76 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Cholelithiasis, Biliary Dyskinesia
Interventions
NOTES Transvaginal Cholecystectomy
Procedure
Lead sponsor
Baystate Medical Center
Other
Eligibility
18 Years and older · Female only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2015
U.S. locations
1
States / cities
Springfield, Massachusetts
Conditions
Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma
Interventions
AZD4360
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 130 Years
Enrollment
117 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
3
States / cities
Santa Monica, California • Providence, Rhode Island • Houston, Texas
Conditions
Cancer
Interventions
capecitabine, irinotecan hydrochloride
Drug
Lead sponsor
Montefiore Medical Center
Other
Eligibility
18 Years to 120 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2003
U.S. locations
1
States / cities
The Bronx, New York
Conditions
Distal Bile Duct Adenocarcinoma, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Intrahepatic Bile Duct Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Stage IVB Gallbladder Cancer AJCC v8
Interventions
Cisplatin, Gemcitabine, Nab-paclitaxel, Quality-of-Life Assessment, Questionnaire Administration
Drug · Other
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
1
States / cities
Duarte, California
Conditions
Primary Biliary Cholangitis
Interventions
Obeticholic Acid 5 MG, Obeticholic Acid 10 MG, Standard of Care: UDCA
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
San Diego, California
Conditions
Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Stromal Tumor, Nausea and Vomiting, Ovarian Cancer, Pancreatic Cancer, Peritoneal Cavity Cancer, Small Intestine Cancer
Interventions
octreotide acetate
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2002
U.S. locations
1
States / cities
Chicago, Illinois