Durvalumab + Histotripsy for Liver Cancer

(CODAH Trial)

This trial explores a new approach to treating advanced intrahepatic cholangiocarcinoma (a type of liver cancer) by combining durvalumab (an immunotherapy drug) with histotripsy, a non-invasive procedure that uses sound waves to break down tumor tissue. The main goal is to determine if this combination can enhance the body's immune response against the cancer and ensure patient safety. Suitable candidates for this trial have been diagnosed with intrahepatic cholangiocarcinoma, have shown disease control after chemotherapy and immunotherapy, and have tumors appropriate for histotripsy treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to advancing cancer treatment.

The trial information does not specify if you need to stop taking your current medications. However, if you are on investigational medication or have had a live vaccine recently, you may need to wait before joining the trial.

A previous study found that durvalumab was generally well-tolerated. About 52% of patients experienced some side effects, but only 6.8% had more serious reactions. No deaths related to the treatment occurred, suggesting it is relatively safe for advanced biliary tract cancer.

Histotripsy also demonstrated promising safety results in treating liver tumors. Serious side effects occurred in only about 7% of patients, indicating an acceptable safety profile. This non-invasive method uses sound waves to break down tumor tissue, enhancing its safety appeal.

Unlike the standard treatments for liver cancer, which typically involve chemotherapy or targeted therapy, the combination of durvalumab and histotripsy offers a novel approach. Durvalumab is an immunotherapy drug that helps the immune system recognize and fight cancer cells more effectively. Meanwhile, histotripsy is a non-invasive technique that uses focused sound waves to break down tumors, potentially enhancing the immune response. Researchers are excited because this combination could lead to more effective tumor destruction while also boosting the body's natural defenses against cancer, offering a hopeful new option for patients with advanced liver cancer.

Research has shown that durvalumab may effectively treat advanced liver cancer. One study found that combining durvalumab with chemotherapy helped patients with advanced biliary tract cancer live longer and reduced the risk of death by 24%. Histotripsy, a technique using sound waves to break down tumor tissue, has significantly shrunk tumors and slowed their growth in liver cancer, according to studies. This method can break up tumors without heat, potentially aiding the body's fight against cancer. In this trial, participants will receive both durvalumab and histotripsy, which together could effectively treat intrahepatic cholangiocarcinoma by enhancing the body's immune response.⁶⁷⁸⁹¹⁰