Ongoing Trial: The EA2222/PUMP clinical trial is testing a new treatment for patients with colorectal cancer that has spread to the liver

Colorectal cancer is the fourth most common cancer in the United States—and approximately one in four patients with the disease will have it spread to their liver. When this happens, the new sites of cancer are called colorectal liver metastases (CRLM). Better treatments are needed to improve outcomes for this relatively large group of patients.

The PUMP research study (EA2222) is for adults with CRLM that cannot be removed by surgery due to the location or size of the cancer. Patients must have completed a 3-6-month course of initial systemic chemotherapy and have not received any radiation therapy to the liver. The PUMP study is exploring second-line treatment with standard chemotherapy with or without additional chemotherapy pumped directly into the liver area through a device implanted by a surgeon. The procedure is called hepatic arterial infusion (HAI) chemotherapy.

The HAI device pumps chemotherapy directly into the hepatic artery, the vessel that supplies blood to the tumors in the liver. This allows for the use of high doses of chemotherapy in the liver while minimizing exposure or side effects in the rest of the body. However, patients who undergo HAI chemotherapy may still have side effects that are worse or different than those associated with the usual treatment. The possible benefit is that HAI chemotherapy, when added to the usual treatment, may be more effective in shrinking or stabilizing the cancer than the usual treatment alone.

Patients who enroll in the PUMP study will be randomly assigned by a computer into two groups. All participants will receive the usual treatment of standard chemotherapy. Half will receive HAI chemotherapy alongside standard chemotherapy. The other half will receive standard chemotherapy only. The goal of this trial is to determine if adding HAI chemotherapy can improve patients' overall survival. After completion of treatment, patients will be followed by their doctor every 3 months for 2 years and then every 6 months for an additional 3 years.

The primary goal of the study is to compare how long patients live after the start of treatment between the two groups. Previous trials for inoperable CRLM have demonstrated a survival advantage for patients treated with HAI chemotherapy. These studies led to the U.S. Food and Drug Administration (FDA) approval in 2021 for a company that manufactures the HAI pump for treating CRLM. However, it is only used in a few oncology centers because it requires specialized surgical and medical oncology training. Most of the time, it is not used until standard chemotherapy stops working. If this trial is successful, it could encourage more cancer centers and hospitals to incorporate HAI chemotherapy into a standard treatment approach.

Learn more about EA2222/PUMP at ecog-acrin.org.