A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
Biliary Tract CancerThis study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection. The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on biliary cancer. In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent, bevacizumab will be tested. Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their disease gets worse or they are unable to tolerate treatment.
GTX Regimen for Biliary Cancers
Biliary CancerThis is a study for patients with advanced cancer of the biliary tree, such as cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of Gemcitabine, Taxotere, and Xeloda every 21 days for at least 9 weeks. Treatment will continue until their cancer progresses. This chemotherapy regimen has been used in pancreatic cancer and there is reason to believe that it will be effective for cancers of the biliary tree as well.
A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing...
Pancreatic NeoplasmsBiliary Tract Neoplasms3 moreThe purpose of this trial is to determine whether a mucosa-to-mucosa technique of pancreaticojejunostomy will improve the pancreatic fistula rate.
Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)
CholangiocarcinomaKlatskin Tumor1 moreThe purpose of this study is to test the safety of giving external beam radiation, followed by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is not amenable for surgical removal, are eligible. The hypothesis is that highly focused high dose radiation delivered using Cyberknife in conjunction with traditional radiation and chemotherapy can improve outcome in this patient population.
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors...
Biliary Tract CancerThe main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer...
Biliary CancerThe primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.
Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary...
Biliary Tract CancerNuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients...
Solid TumorGastric Cancer6 moreThis trial is an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with CLDN18.2-positive tumors. The trial design consists of three parts: Part 1A is a dose escalation of BNT141 as monotherapy in patients with advanced unresectable or metastatic Claudin 18.2 (CLDN18.2)-positive solid tumors for which there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy. The dose of BNT141 will be escalated until the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of BNT141 as monotherapy are defined. Eligible tumor types are gastric cancer, gastroesophageal junction (GEJ) and esophageal adenocarcinoma, pancreatic, biliary tract (cholangiocarcinoma and gallbladder cancer), and mucinous ovarian cancers. Additionally, patients with specific tumors (including colorectal cancer, non-small-cell lung cancer, gastric subtype of endocervical adenocarcinoma) where there is scientific evidence that the CLDN18.2 could be elevated can be tested for CLDN18.2 expression. Part 1B is a dose escalation of BNT141 in combination with nab-paclitaxel and gemcitabine in patients with advanced unresectable or metastatic CLDN18.2-positive pancreatic adenocarcinoma or cholangiocarcinoma who are eligible for treatment with nab-paclitaxel and gemcitabine. Part 1B intends to define the MTD and/or RP2D of the combination. Part 2 with adaptive design elements will be added at a later stage.
A Questionnaire Survey for Biliary Tract Cancers
Biliary Tract CancerThe purpose of this study is: To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program Development of programs by creating a multi-center biliary tract cancer registration system
Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin...
Biliary Tract NeoplasmsCholangiocarcinoma3 moreBackground: 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.