1 |
NCT03201458 |
Recruiting |
Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer |
- Gallbladder Carcinoma
- Intrahepatic Cholangiocarcinoma
- Non-Resectable Cholangiocarcinoma
|
- Drug: Atezolizumab
- Drug: Cobimetinib
- Other: Laboratory Biomarker Analysis
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Incidence of adverse events (AE)s assessed using National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0
- Objective response rate defined as the proportion of response evaluable subjects who have a complete response or partial response assessed by Response Evaluation Criteria in Solid Tumors version 1.1
- (and 2 more...)
|
82 |
All |
18 Years and older (Adult, Senior) |
NCT03201458 |
NCI-2017-01127 ETCTN10139 10139 UM1CA186691 |
|
December 22, 2017 |
June 30, 2019 |
June 30, 2019 |
June 28, 2017 |
April 23, 2018 |
|
- City of Hope Comprehensive Cancer Center
Duarte, California, United States - University of California Davis Comprehensive Cancer Center
Sacramento, California, United States - City of Hope South Pasadena
South Pasadena, California, United States - (and 25 more...)
|
2 |
NCT03043547 |
Recruiting |
Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies |
- Cholangiocarcinoma Non-resectable
- Cholangiocarcinoma Metastatic
- Cholangiocarcinoma of the Gallbladder
- Cholangiocarcinoma Advanced
|
- Drug: nal-IRI
- Drug: 5-FU
- Drug: leucovorin
|
Interventional |
Phase 2 |
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- progression-free survival
- Overall survival
- Objective tumor response rate (ORR) according to RECIST 1.1
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03043547 |
AIO-HEP-0116 2016-003709-33 O16-33033 |
NALIRICC |
October 24, 2017 |
January 2021 |
July 2021 |
February 6, 2017 |
November 17, 2017 |
|
- Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover
Hannover, Germany
|
3 |
NCT01855724 |
Recruiting |
Clinical Trial to Investigate the Efficacy of Treatment With Gemcitabine/Pazopanib in Patients With Biliary Tree Cancer |
- Cholangiocarcinoma
- Gallbladder Carcinoma
- Biliary Carcinoma
|
- Drug: Gemcitabine-Pazopanib
|
Interventional |
Phase 2 |
- Hellenic Cooperative Oncology Group
- GlaxoSmithKline
- Hellenic Cooperative Oncology Group
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Evaluation of Progression-Free Survival (PFS)
- Evaluation of 6-month Progression-Free Survival rate (6-month PFS rate)
- (and 4 more...)
|
46 |
All |
18 Years and older (Adult, Senior) |
NCT01855724 |
HE 37/12 2012-001705-24 |
|
June 2013 |
April 2019 |
October 2019 |
May 16, 2013 |
September 21, 2017 |
|
- 2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital
Athens, Greece - Dept of Medical Oncology, 251 General Air Force Hospital
Athens, Greece - 2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"
Athens, Greece - (and 12 more...)
|
4 |
NCT02923934 |
Recruiting |
A Phase II Trial of Ipilimumab and Nivolumab for the Treatment of Rare Cancers |
- Gastrointestinal Cancer
- Neuroendocrine Tumours
- Malignant Female Reproductive System Neoplasm
|
- Drug: Ipilimumab
- Drug: Nivolumab
|
Interventional |
Phase 2 |
- Olivia Newton-John Cancer Research Institute
- Bristol-Myers Squibb
- Olivia Newton-John Cancer Research Institute
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the clinical efficacy of the combination treatment of ipilimumab with nivolumab in rare cancers.
- To identify whether a common predictive biomarker or immune signature can be identified in responding patients that can occur irrespective of tumour type.
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02923934 |
ONJ2016-001 |
|
August 22, 2017 |
August 2023 |
December 2023 |
October 5, 2016 |
April 10, 2018 |
|
- Austin Health
Heidelberg, Victoria, Australia
|
5 |
NCT03473574 |
Not yet recruiting |
Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients |
- Cholangiocarcinoma
- Gall Bladder Carcinoma
- Cholangiocarcinoma Non-resectable
- Gallbladder Carcinoma Non-Resectable
|
- Biological: Durvalumab and Tremelimumab
- Drug: Gemcitabine
- Drug: Cisplatin
|
Interventional |
Phase 2 |
- AIO-Studien-gGmbH
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response rate (ORR)
- Overall survival (OS)
- Incidence of Treatment Emergent Adverse Events as assessed by NCI CTCAE V4.0 (Safety and Tolerability)
- Quality of Life
|
63 |
All |
18 Years and older (Adult, Senior) |
NCT03473574 |
AIO-HEP-0117 2017-001538-25 |
IMMUCHEC |
March 2018 |
July 2020 |
July 2021 |
March 22, 2018 |
March 22, 2018 |
|
|
6 |
NCT02351765 |
Recruiting |
ABC-08: Phase Ib Trial of Acelarin in Combination With Cisplatin in Locally Advanced/ Metastatic Biliary Tract Cancers |
- Biliary Tract Cancer
- Gallbladder Cancer
- Cholangiocarcinoma
- Ampullary Cancer
|
- Drug: Acelarin
- Drug: Cisplatin
|
Interventional |
Phase 1 |
- The Christie NHS Foundation Trust
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety profile of Acelarin in combination with Cisplatin, assessed by total incidence and rate of grade 3 and 4 adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
- Maximum Tolerated Dose (MTD) of Aclerain in combination with Cisplatin
- Progression-free survival
- (and 3 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT02351765 |
CFTSp096 2015-000100-26 |
ABC-08 |
January 2016 |
February 2019 |
February 2019 |
January 30, 2015 |
March 29, 2018 |
|
- Beatson Oncology Centre
Glasgow, United Kingdom - Clatterbridge Cancer Centre
Liverpool, United Kingdom - Imperial College London
London, United Kingdom - (and 2 more...)
|
7 |
NCT03278106 |
Recruiting |
TAS-102 in Treating Advanced Biliary Tract Cancers |
- Cholangiocarcinoma
- Stage III Gallbladder Cancer AJCC v7
- Stage IIIA Gallbladder Cancer AJCC v7
- (and 4 more...)
|
- Other: Laboratory Biomarker Analysis
- Drug: Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
|
Interventional |
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival rate defined as the proportion of evaluable patients who are progression-free (stable disease, partial response, complete response)
- Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events
- Overall response rate (ORR) defined as the proportion of patients who experience either a partial response or complete response by the given time point
- (and 2 more...)
|
28 |
All |
18 Years and older (Adult, Senior) |
NCT03278106 |
MC1642 NCI-2017-01603 P30CA015083 |
|
October 20, 2017 |
September 15, 2020 |
September 15, 2020 |
September 11, 2017 |
October 25, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|