Active clinical trials for "Biliary Tract Neoplasms"

BACKGROUND: Various tumor ablative procedures and techniques have been shown to result in immunogenic cell death and induction of a peripheral immune response. The term ablative therapies applies to trans-arterial catheter chemoembolization (TACE), radiofrequency ablation (RFA) and cryoablation (CA). The underlying hypothesis of this study is that the effect of immune checkpoint inhibition can be enhanced by TACE, CA and RFA in patients with advanced hepatocellular carcinoma (HCC) and biliary tract carcinomas (BTC). We have already demonstrated proof of principle as well as safety and feasibility of this approach with anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) therapy. Based on the concept of programmed death-ligand 1 (PDL1)-mediated adaptive resistance and the emerging role of programmed cell death protein 1 (PD1) therapy in HCC, we would like to evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in HCC and BTC. Objectives: - To preliminarily evaluate the 6-month progression free survival (PFS) of combining tremelimumab and durvalumab in patients with advanced HCC (either alone or with cryoablation, TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC) (either alone or with cryoablation or RFA). ELIGIBILITY: Histologically or cytologically confirmed diagnosis of HCC or biliary tract carcinoma OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of HCC (or biliary tract carcinoma). Childs-Pugh A/B7 cirrhosis only is allowed. If patient does not have cirrhosis, this limitation does not apply. Patients must have disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation. DESIGN: We will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in cohorts A (HCC; N=40) and B (BTC; N=30). The first N=10 patients in both cohorts will receive tremelimumab and durvalumab only (i.e. No interventional radiologic procedures). A: Advanced HCC, BCLC# Stage B/C N= 1st 10 pts: No ablative procedure Cryoablation/RFA/TACE## Tremelimumab 75mg flat dose every (q)28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until end of study (EOS)### 40 total: 10 trem+ dur alone; 10 trem+ dur + TACE; 10 trem + dur + RFA; 10 trem + dur + cryo B: Intra/extra-hepatic cholangiocarcinoma N= 1st 10 patients (pts): No ablative procedure; RFA/ cryoablation Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until EOS### 30 total: 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem BCLC = Barcelona clinic liver cancer staging system For BCLC stage B patients TACE may be repeated as per standard of care EOS = End of study treatment or meeting any of the off-treatment or off study criteria.

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1 combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy

This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated advanced biliary tract cancer, and to explore the predictive biomarkers for future large-scale clinical trials using this combination.

The objective of this study is to establish the recommended dose of selumetinib, a novel MEK inhibitor for use in combination with gemcitabine and cisplatin.

The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.

The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.

A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.

This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria. Secondary objectives are : Progression free survival, overall survival and safety.

To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.