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35 active trials for Bile Duct Cancer

Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).

Background: Bile duct cancer is cancer of the slender tubes of the biliary tract. These tubes carry bile through the liver. Such cancer tumors often have an abnormal or mutated gene. Researchers think a mix of drugs can slow the progression of gene-mutated cancers of the biliary tract. Objective: To see if using a combination of trametinib and hydroxychloroquine (HCQ) increases the period of time it takes for a person s bile tract carcinoma (BTC) to get worse. Eligibility: Adults age 18 and older with BTC. Design: Participants will be screened with a physical exam, medical history, and cancer history. Their ability to do their normal activities will be assessed. They will have blood and urine tests. They will give a tumor sample. They will have heart tests. They may talk with a heart doctor. They may have an eye exam. They may have a tuberculosis test. They will have computer tomography (CT) scans of the chest, abdomen, and pelvis. They may have magnetic resonance imaging (MRI) scans of the chest, abdomen, pelvis. Participants will repeat some screening tests throughout the study. Participants will take HCQ and trametinib tablets by mouth daily in 28-day cycles. They will have study visits once a month. They will take the drugs until they have bad side effects or the drugs stop working. Participants will have one more tumor biopsies during the treatment. They will have blood taken often. One month after treatment ends, participants will have a safety follow-up visit. Then they will be called or emailed every 6 months for the rest of their life....

Bethesda, MarylandStart: September 2021
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

Background: - Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC). Objectives: - To collect tissue samples for use in studying new ways to treat tumors. Eligibility: Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC. Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care. Design: Before their procedure, participants will have a small blood sample taken. Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours. For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis. Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.

Bethesda, MarylandStart: July 2013
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.

Gainesville, FloridaStart: October 2021
Recurrence After Whipple's (RAW) Study: Investigating Recurrence Patterns After Pancreaticoduodenectomy for Pancreatic, Ampullary or Distal Bile Duct Cancer

Pancreatic head malignancies are aggressive cancers that are often inoperable when they are diagnosed. In the ~20% of patients who are diagnosed when the disease is still operable, surgery is the only treatment that can provide a chance of cure. Unfortunately, up to 75% of patients undergoing surgery will have the cancer come back (recur). One of the reasons for this is the challenge of removing the whole tumour with some surrounding non-cancerous tissue to ensure that every tumour cell has been removed. This is difficult because there are many structures very close to the pancreas (such as the blood vessels that supply the intestines) that cannot be removed. A recent review study of >1700 patients who had a Whipple's operation (the cancer operation that is performed to remove the head of pancreas) and found that whilst the majority of patients had cancer recurrence in distant sites (like the liver) that would not be affected by how the operation was performed, 12% of patients had the cancer recur just at the site of where the operation had been; this is known as 'local' recurrence. This suggests that a small amount of cancer was not removed at the time of surgery in these patients. Very few studies have looked at the relationship between the Computerised Tomography (CT) scan before surgery and the histology results (information about the tumour after it has been examined under the microscope) and whether this can predict exactly where the tumour recurs. If investigators can find factors that predict which patients get local only recurrence, investigators may be able to offer improved surgical techniques or other therapies during or immediately after the operation to these patients, hopefully leading to improved cure rates. This retrospective international study will look at these factors in patients who underwent a Whipple's operation for pancreatic cancer, bile duct cancer or ampullary cancer over a three year period between 2012 and 2015. Participating centres will provide data on pre-operative scans, complications around the time of surgery, any therapies (e.g. chemotherapy) that the patients had and if and where the cancer recurred. With this information, investigators hope to find ways to predict which patients will get local-only recurrence, so researchers can select them for future studies to see if additional treatments can improve the chance of cure from surgery for these patients.

Sassari, SardiniaStart: October 2020
A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

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-CTLA4 therapy. Based on the concept of PDL1-mediated adaptive resistance and the emerging role of 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 q28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until 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 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.

Bethesda, MarylandStart: July 2016
Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)

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.

Bethesda, MarylandStart: June 2017
Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer

90 % of the patients with bile duct cancer are not justifiable of a surgical resection with curative aim for oncologic reasons ( metastatic extensions), for reasons of resectability (canalar extension, vascular) or still for surgically reasons (age, comorbidity). The palliative care of these patients consists at first in assuring an effective biliary drainage, infectious complications being one of the main causes of death. The biliary drainage allows to improve the survival of these patients. It bases by the implementation, by the endoscopic or percutaneous way of biliary, generally metallic prosthesis the duration of average permeability of which is of approximately 6 months. The standard oncologic treatment is the administration of a chemotherapy exclusive or associated with a radiotherapy. The radiotherapy and the radio chemotherapy did not show efficiency on the survival superior to the exclusive biliary drainage. The first-line exclusive chemotherapy bases on the gemcitabine-cisplatin association with a median survival of 11,6 months. No study allows to justify the administration of a chemotherapy of the second line. Thus the preservation of the permeability of the biliary ways is today, the most important factor to improve the survival of these patients. Therefore, the addition of a treatment allowing to obtain a local tumoral response to the insertion of biliary prosthesis would allow to increase the duration of permeability of the biliary prosthesis and would limit the local evolution. Endoductal destruction tumoral technics were thus developed in this indication: Dynamic phototherapy which demonstrated, during preliminary studies, a certain efficiency both on the tumoral response estimated on the improvement of the tumoral stenosis as on the survival in case of cholangiocarcinoma bile ducts not resectables. However, the improvement of the survival was not confirmed by wider randomized studies. A study randomized of phase III was interrupted prematurely because of a survival decreased in the experimental arm. The radium therapy and the brachytherapy were estimated in this indication with results interesting on series limited in size, but is not used in routine because of its cost and of technics difficulties. Ablation therapy technics (radio frequency, microwaves, radium therapy) percutaneous by radiological or surgical way proved their efficiency for the treatment of hepatocarcinoma and liver metastasis. The hepatic radio frequency was estimated, during trials of phases II, for peripheral cholangiocarcinoma intra hepatic (developed at a distance main bile ducts) with interesting tumoral rates of necrosis. However, the direct percutaneous access of the cholangiocarcinoma of the biliary ways is not practicable because of the risk of iatrogenic biliary fistula. Therefore, systems allowing to realize ablation therapy by endoductal radio frequency are from now on available. It is miniaturized bipolar probes which are inserted into bile ducts by reactionary way (retrograde cholangiography), or anterograde percutaneous. Two systems (Habib ®, ELLRA ®) are at present available and were estimated during in vitro and in vivo studies, to the animal and in man. The purposes of this study are to estimate the feasibility, the efficiency and the morbidity of the biliary radio frequency for the treatment of the extra hepatic cholangiocarcinoma non resectable (resection or transplantation).

MarseilleStart: March 2018
Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer

This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.

Seattle, WashingtonStart: July 2020