This trial is evaluating whether M7824 will improve 2 primary outcomes and 31 secondary outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of At Day 1 and Day 29.
This trial requires 159 total participants across 2 different treatment groups
This trial involves 2 different treatments. M7824 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 2 and have already been tested with other people.
In a recent study, findings suggest that biliary tract cancer is caused by a combination of environmental and genetic factors, and it may be related to chronic occupational exposure. However, the data are limited by the lack of data on exposure and genetic susceptibility.
Biliary tract cancer is a cancer that forms in the bile duct, a hollow canal that forms the main part of the hepatic tract. It causes swelling, pain, and other symptoms in a specific part of the body. Chronic liver disease is common in those with biliary tract cancer. It also increases the risk of getting liver cancer. The signs of bile duct cancer typically start in the midsection or upper right area of the abdomen, especially if it is painless. Liver tumors are uncommon in people with cirrhosis and can be found either on the surface of the liver or inside the organ. Tissue from the liver may appear yellow-white in the stool.
Treatment for patients with biliary tract cancer is similar to other types of cancer, but it is unique in some aspects, such as the role of neoadjuvant chemotherapy.
Most commonly, symptoms include an increased liver function test result. Biliary tract cancers may cause jaundice due to obstruction of the biliary ducts by a mass. Other signs include abdominal pain, unexplained weight loss or an unintentional weight loss over three months, and itchiness. Abdominal bleeding may or may not be present. \n
It was not clear whether the biliary cancer diagnosed to be due to choledochal cyst, benign or malignant. It is necessary for health care provider's to keep surveillance system in the areas with high risk of biliary cancer.
Only 18% of patients would have developed biliary tract cancer after 12 years. The highest incidence rate was in cases with concomitant cirrhosis (32%), chronic infection, and carcinogenesis secondary to bile duct stones (26%), while the lowest rate was in cases with only chronic pancreatitis (only 9%). To prevent progression, a long, early treatment regimen is recommended.
Currently there are 2 treatment options: surgery and [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy). Surgery has the best prognosis, but many patients will recur after the 1st procedure, and sometimes patients will even die. The recurrence rates of resection are as high as 40%; the mortality rates are 2 to 5%. The only way to guarantee that surgeons obtain a radical resection and that their patients will survive is to start immunotherapy at the early stage. At the present time, the use of adjuvant chemotherapy after resection is recommended.
Primary biliary tract cancer may result from a genetic mutation in the β-catenin Tcf factor 3 gene of patients with a hepatic background, but more advanced age, sex, gallstones and gallbladder cancer may also play a part in the development of the disease.
The antitumor activity of M7824 in vivo is correlated with changes in expression of Bcl-2 and Bcl-xL and concurrent sensitization of the cells to chemotherapeutic drugs. Thus, M7824 might represent a new approach to overcome chemoresistance in tumors which are associated with loss of apoptosis.
Mild nausea and vomiting were seen in 5 of the 16 patients in the 100 mg tiwaferan-100 arm and 2 of 16 in the 400 mg tiwaferan-100 arm, respectively. No patients in either arm experienced severe grade toxicity or severe toxicity to any specific dose/schedule. M7824 induced no toxicities that would warrant cessation. Based on the aforementioned clinical data, we conclude that M7824 is experiencing a good safety profile compared to that of other biologics and its own monoclonal antibody, m1488.
The protein's name originates from the molybdenum cofactor, or Mo-pterin, part of the electron transport chain of bacterial and chloroplastic photosynthesis. However, as the name of the protein appears to be derived from the name of a species it has never been found in. [http://pubs.biot.cs.ic.edu/biot/biochips.csp_ref=refs?ref_id=cobi_mf2&ref_ref_id=bdb_mfe.