UC Davis Health Clinical Studies

Experimental TAS-102 and Irinotecan for Gastric and Gastroesophageal Adenocarcinoma (stomach cancer)

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The purpose of this research study is to test the experimental combination of TAS-102 and irinotecan. We hope to learn if it is effective in patients with gastric or gastroesophageal cancers (GEC). Both TAS-102 and irinotecan are used to treat GEC and are included in treatment guidelines. Irinotecan is not approved to treat gastroesophageal cancers. TAS-102 was approved in 2019 for patients with advanced GEC who have no other standard chemotherapy options. This is the first study to test the combination of TAS-102 and irinotecan in advanced GEC. There has been a previous study using this combination in patients with metastatic colon cancer. It was shown to have some anti-tumor effects and the dose and schedule of the combination was shown to be tolerable. We would like to see if there are similar effects in patients with advanced GEC. The purpose of this research study is to see if the combination of TAS-102 and irinotecan can slow down tumor growth in patients.

Drug study, Phase 1
Any, age 18 years or older

A Study of Experimental ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (liver cancer)

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The purpose of this study is to find out if Study Drug ET140202 T cells are safe and if there are beneficial effects in people with liver cancer. The investigational study drug is ET140202 T cells. The word “investigational” means the study drug is still being tested in research studies and is not approved by the FDA. Your ET140202 T cell product will be made from your own T cells, a specific type of white blood cell. Your T cells will be genetically-modified in the laboratory. This means the T cells are changed by inserting additional pieces of DNA (genetic material) into the cells. This makes them recognize and kill liver cancer cells. The process of making your ET140202 T cell product is described here: • Your cells will be collected by a procedure called leukapheresis. This involves collecting your blood and separating your white blood cells from other blood components. • Your T cells, a specific type of white blood cell, will be isolated and grown in the laboratory. • Your T cells will be treated with a vector. Vectors are type of virus that can enter cells and can change the way the cell acts. • After adding the new ET140202-specific genetic material, your ET140202 T cells will be grown to larger numbers. Afterwards, the cells are washed to select the best cells and frozen. • Your ET140202 T cells will be tested to make sure they are safe for use and then administered to you.

Biological study, Phase [/1/,/ /2/]
Any, age 18 years or older

A Study of Experimental CC-90001 For Non-alcoholic Steatohepatitis (NASH) and Stage 3 or 4 Liver Fibrosis

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We invite you to take part in a research study because you have been diagnosed with nonalcoholic steatohepatitis (NASH). NASH is a type of fatty liver disease in which fat builds up in your liver and over time causes inflammation (swelling) and liver cell damage. The purpose of this study is to test an experimental study drug called CC-90001. This study will test 3 doses of CC-90001 (100 mg, 200 mg and 400 mg, given by mouth, once daily). It will be compared to placebo (a “sugar pill”, an inactive substance that contains no medicine but looks exactly the same). This study is being done to test the effect of CC-90001 on your liver, and how well your body tolerates CC-90001. The study drug, CC-90001, has not been approved for the treatment of NASH and its use in this study is experimental.

Drug study, Phase 2
Any, age 18 years or older

A Study of the Safety and Effectiveness of Experimental Cilofexor for Primary Sclerosing Cholangitis (scarring of bile ducts)

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We invite you to take part in a research study because you have primary sclerosing cholangitis (PSC). PSC is a chronic disease which causes scarring of the bile ducts. When the bile ducts are damaged, the ducts become hard and narrow and this can block the flow of bile which can cause damage to the liver over time. This study will test an experimental drug named GS-9674 (also referred to as cilofexor). It will be used for the treatment of primary sclerosing cholangitis (PSC). PSC can be without symptoms, especially early in the disease. Some symptoms of PSC can include fatigue (feeling tired), itching, and jaundice (yellowing of eyes and skin). The symptoms of PSC are related to the blockage of bile flow from the scarred bile ducts and a build-up of bile acids. Patients with PSC can develop cirrhosis (severe scarring of the liver). This can lead to liver failure. PSC is also a major risk factor for the development of cancer of the bile ducts (cholangiocarcinoma). The only effective treatment for PSC is liver transplantation. This involves removing the damaged liver and replacing it with a healthy one from a donor. Experimental GS-9674 is being developed to reduce bile acids. Elevated bile acids contribute to symptoms of PSC including inflammation and fibrosis (scarring) in the liver.

Drug study, Phase 3
Any, age 18 to 70 years old

Do you have Fatty Liver or NASH? Participate in a study

We are evaluating a new investigational medicine for the treatment of NASH

We're inviting people with fatty liver or nonalcoholic steatohepatitis (NASH) to participate in a research study. The goal of this study is to see if an investigational medicine called Elafibranor is safe and effective for the treatment of NASH. Nonalcoholic steatohepatitis or NASH is a liver disease that is affecting millions of Americans. It is marked by liver inflammation and damage caused by a buildup of an unhealthy amount of fat in the liver. NASH may progress to scarring and lasting damage to the liver. Currently, no FDA approved medications are available. You will receive study medication and study evaluations at no cost, and compensation for your time is available. Experienced clinicians at the UC Davis Department of Gastroenterology and Hepatology will take care of all study participants.

Phase 3, Drug study
Any, age 18 - 75 years
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