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Gallbladder Neoplasms clinical trials

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NCT ID: NCT03278106 Completed - Cholangiocarcinoma Clinical Trials

TAS-102 in Treating Advanced Biliary Tract Cancers

Start date: October 20, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

NCT ID: NCT03260712 Completed - Metastatic Cancer Clinical Trials

Pembrolizumab in Biliary Tract Cancer

Start date: January 7, 2020
Phase: Phase 2
Study type: Interventional

This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.

NCT ID: NCT03111732 Completed - Liver Cancer Clinical Trials

Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)

Start date: June 14, 2017
Phase: Phase 2
Study type: Interventional

Background: Biliary tract cancers are rare but they are serious. Researchers want to see if a certain drug helps the immune system fight cancer cells. The drug is called pembrolizumab. It may work even better with two chemotherapy drugs that are widely used to treat gastrointestinal cancers. Objective: To study if pembrolizumab given with capecitabine and oxaliplatin (CAPOX) increases the time it takes for a person's biliary tract cancer to get worse. Eligibility: People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body Design: Participants will be screened with tests as part of their regular cancer care. Each study cycle is 3 weeks. For 6 cycles, participants will: Get pembrolizumab and oxaliplatin on day 1 of each cycle. They will be given in an intravenous (IV) catheter. Take capecitabine by mouth for 2 weeks then have 1 week without it. Participants will complete a patient diary. Starting with cycle 7, participants will get only pembrolizumab. They will get it once every 3 weeks. On day 1 of every cycle, participants will have: Physical exam Review of symptoms and how well they do normal activities Blood tests Every 9 weeks, they will have a scan. Participants may have tumor samples taken. Participants will have a final visit about 1 month after they stop the study drug. After that, they will be contacted by phone or email yearly.

NCT ID: NCT02778308 Completed - Gallbladder Cancer Clinical Trials

Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

Start date: January 2012
Phase: N/A
Study type: Interventional

Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. Higher incidence has been noted in Chile, Mexico and Southwest American Indians.[1] It is the third most common malignancy in India.[2] The disease may mimic benign disease in presentation.Up to 1/3rd of patients may present with jaundice but of these only 7% will be resectable.[4] With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease and 63% for stage III have been reported.[5] Treatment of choice is complete surgical resection. The role of chemotherapy and radiotherapy is not very well documented in treatment of gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant chemotherapy or chemo-radiotherapy seems a rational therapeutic option. Gemcitabine with or without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin was found to be more effective than gemcitabine alone and provides definite survival advantage and progression free survival.[6] An earlier randomized trial done to assess the efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement in disease free and overall 5 year survival.[7] But this study has included patients with suboptimal resection and all pancreato-biliary malignancy. In view of these observations this study is being designed to assess the efficacy of the chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone curative resections.

NCT ID: NCT02692911 Completed - Gallbladder Cancer Clinical Trials

Chile Biliary Longitudinal Study

Start date: January 11, 2017
Phase:
Study type: Observational

Background: The gallbladder is a small organ below the liver. Gallbladder cancer is a leading cause of cancer death among women in Chile. Chile also has among the highest rates of gallbladder cancer and death in the world. Researchers in a high-risk region of Chile want to find out more about this type of cancer. They especially want to know how inflammation affects the way it develops. Objective: To better understand the causes of gallbladder diseases and factors that may be associated with them. Eligibility: Women ages 50 74 with gallbladder cancer who are covered by the Chilean national health system. Other people over age 21 with gallbladder disease. Healthy adults over age 21. Design: Participants may be screened with an ultrasound. They may be asked questions about their health. Participants will have an ultrasound of the abdomen. This can be done at the study clinic or in the hospital or at home. The ultrasound uses sound waves to take pictures of the gallbladder. Participants will have a physical exam. Participants will have their mouths looked at for tooth loss, dentures, and gum redness. Participants will give a blood sample or saliva sample. Participants will be asked for access to their medical history. They may be asked to allow researchers to keep any samples taken during gallbladder surgery. Participants will answer questions about their medical history. This will include illnesses, surgeries, medicine use, and family history. It will also include diet and lifestyle habits, such as places where they have lived and worked. Some participants will have 3 follow-up visits over 6 years. ...

NCT ID: NCT02520141 Completed - Cholangiocarcinoma Clinical Trials

Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

Start date: December 29, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT02489422 Completed - Depression Clinical Trials

Programs To Support You During Chemotherapy

PRO-YOU
Start date: August 2016
Phase: N/A
Study type: Interventional

This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.

NCT ID: NCT02430662 Completed - Clinical trials for Gallbladder Neoplasms

Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms

IRE
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.

NCT ID: NCT02392637 Completed - Clinical trials for Unresectable Gallbladder Carcinoma

Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers

Start date: April 2, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver) that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

NCT ID: NCT02351765 Completed - Cholangiocarcinoma Clinical Trials

ABC-08: Phase Ib Trial of Acelarin in Combination With Cisplatin in Locally Advanced/ Metastatic Biliary Tract Cancers

ABC-08
Start date: January 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the recommended phase II dose, and to assess the safety of acelarin in combination with cisplatin in patients with locally advanced/ metastatic biliary tract cancers.