UC Davis Health Clinical Studies

Experimental Cisplatin and Combination Chemotherapy in Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

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This research study is for people diagnosed with very low risk hepatoblastoma. Hepatoblastoma (HB) is a type of cancer that occurs in the liver. HB is considered very low risk when it is surgically removed at diagnosis. The term risk refers to the chance of the cancer coming back after treatment. Treatment for very low risk HB depends on how the cancer cells look under a microscope (histology). One type of histology is called well-differentiated fetal (WDF) histology. This usually requires surgery to remove the tumor, followed by close monitoring until signs or symptoms appear or change. Patients who do not have WDF histology also have surgery to remove the tumor. After surgery, these patients have chemotherapy (cancer fighting medicine) to kill any cancer cells that are left. A common treatment is a combination of 3 chemotherapy drugs called C5V: - cisplatin - 5-fluorouracil - vincristine Because hepatoblastoma is rare, there is limited research in this area. In this study, multiple research groups in Europe and Japan will combine efforts to study the treatment of patients with HB. Researchers want to find out if we can improve the treatment for subjects with very low risk HB. This study looks at how well cisplatin alone (without 5-fluorouracil and vincristine) works when it is given to children and young adults with very low risk HB after surgery. Success with giving cisplatin alone has been observed by European researchers. However, giving cisplatin without 5-fluorouracil and vincristine is experimental in North America. This study also looks at whether we can shorten the chemotherapy treatment given after surgery, from 4 cycles to 2 cycles. Shortening chemotherapy after surgery is also experimental. By removing 2 drugs and shortening chemotherapy, we may be able to reduce side effects during treatment or in the future.

Drug study, Phase [/2/,/ /3/]
Any, age -1 to 30 years old

Primary Biliary Cholangitis with incomplete response or intolerant to ursodeoxycholic acid? Participate in a clinical trial

Help us evaluate if a new investigational drug is safe and effective in the treatment of PBC

We invite you to take part in a research study because you have primary biliary cholangitis (PBC) and you are not responding well enough to or can't tolerate ursodeoxycholic acid. You must have been taking a stable dose of ursodeoxycholic acid (UDCA) for the past twelve months, OR you're not able to tolerate UDCA due to side effects. This study will test the safety and efficacy of an investigational medicine called seladelpar. Previous research has shown that seladelpar may help treating the signs and symptoms of PBC, lower your alkaline phosphatase level, and decrease itching. Primary Biliary Cholangitis (PBC) is a autoimmune chronic liver disease that destroys the bile ducts within the liver. You will receive all study medication and study evaluations at no cost, and compensation for your time may be available.

Drug study, Phase 3
Any, age 18 to 75 years old

A Study of Experimental Nivolumab After Combined Modality Therapy For High Risk Stage II-IIIB Anal Cancer

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This study will examine if adding nivolumab after standard chemotherapy and radiation prevents anal cancer from returning. Nivolumab is an experimental medicine also known as OPDIVO®. Standard chemotherapy includes mitomycin-C and 5-fluorouracil (5-FU) or capecitabine or 5-FU and cisplatin. Nivolumab is a drug that may turn on the body’s immune system to attack any cancer cells that may remain after chemotherapy and radiation. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will test whether this different treatment is better, the same, or worse than the usual treatment for anal cancer. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.

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

A Study of the Experimental Combination of Chemotherapy, Bevacizumab, and/or Atezolizumab For Metastatic Colorectal Cancer

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The purpose of this study is to learn the benefits of adding an experimental drug, atezolizumab (MPDL3280A), to a usual treatment. It will be compared to giving the experimental drug alone and giving the usual treatment alone. The usual treatment in this study is the chemotherapy drugs, 5-flouorouracil (5-FU), leucovorin, and oxaliplatin. This combination is called FOLFOX. In addition to FOLFOX, bevacizumab will be given. Bevacizumab is in a group of drugs called biologic therapy. FOLFOX and bevacizumab are approved by the FDA to treat metastatic CRC. To be better than FOLFOX, the experimental treatment should keep your cancer from growing for more than 7 months. Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual treatment and when given alone. Atezolizumab may keep your cancer from growing but it can also cause side effects. Atezolizumab is FDA-approved for treating metastatic cancers of the bladder and lung. Atezolizumab is considered experimental in this study because it is not approved to treat metastatic CRC. This study has three study groups that will be chosen randomly: • Group 1 will get FOLFOX and bevacizumab. • Group 2 will get atezolizumab alone. • Group 3 will receive FOLFOX and bevacizumab plus atezolizumab.

Drug study, Phase 3
Any, age 18 years or older

An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

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This study will learn more about people with hepatitis B. By doing this study, researchers hope to: • Find out more about patients that have hepatitis B, including their age, race/ethnicity, and other medical conditions they may have • Learn about different medications, procedures, and other treatments that are being used to manage hepatitis B. • Understand changes that may be happening in the liver or throughout the body by looking at reports such as those for scans, tests, and biopsies

Other study
Any, age 18 years or older
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