This trial is evaluating whether Regorafenib will improve 2 primary outcomes and 4 secondary outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of At the end of each cycle (28 days) until disease progression or 2 years (end of study), whichever occurs first.
This trial requires 40 total participants across 2 different treatment groups
This trial involves 2 different treatments. Regorafenib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Approximately 16,000 new cases of biliary tract cancer are diagnosed each year in the United States. This results in a death rate of around 3,000 people each year. In addition to a higher rate of mortality, the patients diagnosed with biliary tract cancer also have substantially longer overall and disease-free survival times than patients diagnosed with other cancers.
Biliary tract cancer, also referred to as biliary cancer, is an aggressive disease of hepatic bile ducts and gallbladder. More than 50% of cases have an underlying primary site in gastrointestinal tract, and over half of cases are caused by cholangiocarcinoma. Bile duct cancer is the primary reason for mortality in patients with biliary tract cancer. The average age of diagnosis is 61. The disease is diagnosed in less than 15 % at the time of first symptoms.
Bicompressive symptoms of the jaundice, abdominal mass or abdominal pain are highly suggestive of cancer. Other significant symptoms may be jaundice, haematuria, hepatocellular growth, leukocytosis or decreased white blood cell count.\n
A number of treatment options are available for biliary tract cancer. Surgery may be the most effective therapy, but for symptomatic tumors, it may be ineffective and may not be a definitive treatment for the disease. For advanced or metastatic disease, palliative care may be necessary. No treatment is effective for prevention. If an intact gallbladder is present, cholangiocarcinoma may be treated with an appropriate surgical resection. In terms of treatment for recurrent disease, surgery may be preferable with radiation or chemotherapy before chemotherapy. Chemotherapy offers a chance of long-term survival, especially in the setting of curative procedures.
Biliary tract cancers can be cured. Despite advances in diagnostics, multimodality oncological treatments are not yet validated for biliary tract cancer. Further, new data on the role of immunomodulatory agents and on the treatment of secondary cholangiocarcinoma are required.
Multiple carcinogens, such as tobacco, are associated with biliary tract cancer. In most cases, a specific type of cancer must occur before biliary tract cancer appears in an individual. Biliary tract cancer can also be caused by gallstones left in the duodenum long enough for bacterial infection to occur. This infection may be from the bacteria, or the bacteria may be the cancer. The last theory may account for why older patients are at increased risk for biliary tract cancer. It seems to occur after age 50 years.
[Carcinogenesis of biliary tract cancer is related to the development of chronic inflammations in a relatively long period with high susceptibility to carcinogenic factors. The carcinogenesis is the most influential factor in the development of biliary tract cancer, and biliary tract cancer tends to occur in the elderly.
There are few data on the survival, treatment response, or the incidence of the spread of biliary tract cancer. Thus, the best available information from many centers, including this study, on survival and treatment response to treatment should be interpreted cautiously, and a randomized trial should be conducted in the future to define the survival of patients who have biliary tract cancer.
Findings from a recent study do not support the notion that the occurrence of any of the 3 biliary tract tumors in either the affected family members or the available case controls were significantly different from that in the general population. We must now look at modifier genes and gene-gene interactions in a population-based, rather than family-based study.
Recent advances in biliary tract cancer therapy have improved local control and overall outcome. New approaches use minimally invasive surgical treatments to keep the cancer in check and treat metastases. Immunotherapy with immune checkpoint inhibitors has been a mainstay in chemotherapy of advanced biliary tumors. Chemotherapy remains the mainstay of therapy for resectable disease. The new generation of targeted therapy agents with tyrosine kinase inhibitors like ALK-positive tumors, gastroesophageal cancer, and EGFR-mutant tumors continues to improve overall outcomes. Radiation continues to be the standard of care in biliary tract cancer treatment and can reduce local recurrence by 55%.
For every 100,000 people in the United States, there were an average of 25 biliary tract cancers in men and 16 in women. Because men are usually older than women, the rate of biliary tract cancer is higher in men than in women.
The mortality of patients with pancreatic cancer and extrapancreatic bile duct cancer is comparable. However, in patients with bile duct cancer (CBD), a high percentage of patients (42%) will die of liver failure. The current study will help physicians, oncologists, and patients understand the disease process, and how serious it can be.