Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations...
Advanced CholangiocarcinomaFGFR2 Gene MutationInfigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.
Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer
Biliary Tract CancerCholangiocarcinomaThe NEOBIL study aims to investigate the feasibility, safety and efficacy of neoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer.
Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers...
Adult Primary Cholangiocellular CarcinomaAdvanced Adult Primary Liver Cancer9 moreThis phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cediranib maleate together with combination chemotherapy may kill more tumor cells.
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.
Dose Escalation Study Combining Oral Capecitabine (Xeloda) and Radiotherapy for Patients With Unresectable...
Cancer of LiverOur long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. The primary objective is to determine the maximum tolerated dose of capecitabine used along with 3-D conformal radiation therapy. Capecitabine will be taken by mouth each day of radiation. The total daily dose should be taken as two divided doses approximately 12 hours apart, within 30 minutes after eating, ideally after breakfast and the evening meal. The overall total number of patients expected to participate in this study could be as high as 30 depending on how the treatment is tolerated. The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m² (level 1) and radiation. If the first group does well, the second group of patients on the study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another 3-6 patients at the lower dose. After the highest tolerated dose is identified, 12 additional patients will be treated at that dose to further test the safety of the treatment and better understand the effects of the treatment on disease with more patients. The following tests and procedures are part of regular medical treatment (standard care) for the disease and are also required for this study. physical examinations blood tests including pregnancy test urinalysis ECG (heart tracing) chest X-ray CT scan of the abdomen Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months for 2 years.
Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
Extrahepatic Bile Duct CancerGallbladder Cancer1 moreRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced...
NeoplasmsColorectal Neoplasms30 moreThis study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated...
Hepatocellular CarcinomaBile Duct CancerThe purpose of this study is to explore the ability of positron emission tomography (PET) with [68Ga]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy.
Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and...
CholangiocarcinomaPancreatic CancerThe purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.
A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma...
CholangiocarcinomaPrimary objective: To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectives:The progression-free survival ,The disease control rate ,The overall survival ,The toxicity profiles , The correlation between clinical outcomes and the potential predictive biomarker for tumor response