Clinical trials: Disorders of Biliary Tract
Gastrointestinal Cancer, Pancreatic Cancer
Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
The primary objective of this prospective observational study is to characterize the gut and oral microbiome as well as the whole blood transcriptome in gastrointestinal cancer patients and correlate these findings with cancer…
- Conditions
- Gastrointestinal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer
- Trial name
- NCT05462314
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Viome
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
Primary Biliary Cholangitis (PBC)
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone…
- Trial name
- NCT07304843
- Testing
- golexanolone
- Where
- 38 sites in Germany, Greece and 6 more
- Volunteers
- 207 people
- Sponsor
- Umecrine Cognition AB
Gastrointestinal Epithelial Cancer, Gastrointestinal Neoplasms
A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering
A clinical trial to assess the safety and efficacy of genetically-engineered, neoantigen-specific Tumor Infiltrating Lymphocytes (TIL) in which the intracellular immune checkpoint CISH has been inhibited using CRISPR gene editing…
- Conditions
- Gastrointestinal Epithelial Cancer, Gastrointestinal Neoplasms, Cancer of Gastrointestinal Tract, Cancer, Gastrointestinal
- Trial name
- NCT04426669
- Testing
- Cyclophosphamide, Fludarabine, Tumor-Infiltrating Lymphocytes (TIL)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Intima Bioscience, Inc.
BCL2 Gene mRNA Overexpression
Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study
- Trial name
- miRNA_Chip (NCT02807896)
- Where
- South Korea
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- CHANGHEE LEE
Breast Cancer, Prostate Cancer
Tempus Priority Study: A Pan-tumor Observational Study
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with…
- Conditions
- Breast Cancer, Prostate Cancer, Bladder Cancer, Lung Cancer
- Trial name
- NCT05179824
- Testing
- Observation
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Tempus AI
Primary Sclerosing Cholangitis
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional…
- Trial name
- ELMWOOD (NCT05627362)
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 62 sites in United States, Canada and 5 more
- Volunteers
- 68 people
- Sponsor
- Ipsen
Advanced MTAP-null Solid Tumors
A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of Anvumetostat alone and in combination with…
- Trial name
- MTAPESTRY 101 (NCT05094336)
- Testing
- Anvumetostat, Docetaxel, Comparator Anvumetostat Test Tablet
- Where
- 75 sites in United States, Australia and 12 more
- Volunteers
- 329 people
- Sponsor
- Amgen
Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC)
To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors
The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with…
- Conditions
- Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC), Hepatocellular Carcinoma (HCC), Gastric Cancer (GC)
- Trial name
- NCT07594964
- Testing
- XH001 Injection, mFOLFIRINOX Treatment Regimen
- Where
- 2 sites in China
- Volunteers
- 48 people
- Sponsor
- Shenzhen Xinhe Biomedical
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Acute Cholecystitis, Colorectal Cancer
Safety and Feasibility of ActivSightTM in Human
ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery.
- Conditions
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid
- Trial name
- NCT04633512
- Testing
- ActivSight
- Where
- 3 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Activ Surgical
Primary Sclerosing Cholangitis
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT03394781
- Testing
- DUR-928
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Durect
Biliary Obstruction, Bile Duct Stricture
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY…
- Conditions
- Biliary Obstruction, Bile Duct Stricture, Bile Duct Diseases
- Trial name
- NCT04929821
- Testing
- Biliary Duct Stenting
- Where
- 6 sites in Hong Kong, India and 1 more
- Volunteers
- 100 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Primary Sclerosing Cholangitis
A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
- Trial name
- NCT02704364
- Testing
- NGM282
- Where
- 38 sites in United States, France and 2 more
- Volunteers
- 62 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Solid Tumor, Solid Carcinoma
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV)…
- Conditions
- Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Cancer
- Trial name
- MAST (NCT05346484)
- Testing
- CF33-hNIS, Pembrolizumab, Modified FOLFOX
- Where
- 12 sites in United States, Australia
- Volunteers
- 66 people
- Sponsor
- Imugene Limited
Liver Cancer, Pancreas Cancer
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers .
- Conditions
- Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer
- Trial name
- NCT04014478
- Testing
- Endovascular Denervation
- Volunteers
- 110 people
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Biliary Stricture, Biliary Anastomotic Stenosis
DIGEST I Drug Coated Balloon for Biliary Stricture
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
- Conditions
- Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease
- Trial name
- DIGEST (NCT03997994)
- Testing
- GIE Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 8 people
- Sponsor
- GIE Medical
Biliary Tract Cancer, Cholangiocarcinoma
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gall Bladder Cancer, Ampullary Cancer
- Trial name
- NCT05506943
- Testing
- CTX-009, Paclitaxel
- Where
- 34 sites in United States
- Volunteers
- 168 people
- Sponsor
- Compass Therapeutics