The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with high-risk resectable intrahepatic cholangiocarcinoma for a research study. The purpose of this study is to test the good and bad effects of the drug called durvalumab in combination with the chemotherapy drugs gemcitabine and cisplatin. This drug combination could shrink your cancer, but it could also cause side effects. The study doctors hope to learn if this drug combination will improve surgery outcomes in people with your type of high-risk liver cancer. The combination of gemcitabine, cisplatin, and durvalumab has been approved by the FDA as front line therapy for advanced biliary tract cancers, including intrahepatic cholangiocarcinoma. This regimen is approved by the FDA for treatment of your disease when it is advanced and cannot be removed with surgery; it is currently not routinely given before surgery.
The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. You will get the combination of durvalumab, gemcitabine, and cisplatin through a vein in your arm on the first day of each cycle and the chemotherapy drugs, gemcitabine and cisplatin, again on the eighth day of each cycle. Each cycle lasts 21 days. This part of the study has 4 cycles and then you will undergo surgery. After surgery there will be 4 more cycles of the drug combination, for a total of 8 cycles. After you finish your treatment, your doctor will continue to follow your condition in accordance with standard of care, with visits to the office every 3 months for the first two years after surgery, every 6 months for the following five years, and on a yearly basis thereafter. Your doctor will watch you for side effects and for surveillance.
The investigational drug, durvalumab, will be provided by the study at no cost to you. All additional procedures required by the study beyond your standard care, including laboratory tests, are provided to you at no charge.
Additional information can be found here: https://clinicaltrials.gov/study/NCT06050252
No Compensation