Liver Cancer Clinical Trial
When a tumor in the liver is too large or extensive to be removed by surgery, doctors have other options to neutralize the tumor.
One of those options is transarterial chemoembolization, in which a chemotherapy drug is fed through a tiny catheter into arteries that feed the tumor in the liver. The treatment is intended to kill the tumor, while preventing harm outside of the tumor by keeping the drugs locked inside.
But chemoembolization is considered a palliative treatment because it does not fully eliminate the cancer, and the human body typically resists or becomes resistant to the drugs over time.
Wake Forest Baptist Health is among a group of hospitals nationwide and one of three in North Carolina participating in a national study combining chemoembolization with another drug, called Sorafenib, that inhibits growth of cancer cells. Sorafenib is a pill, taken orally.
"The goal with this trial is progression-free survival,'' says Perry Shen, MD, surgical oncology fellowship program director for Wake Forest Baptist. "Given this treatment, how long can we lengthen the time before the tumor starts growing again? We want to increase the progression-free survival.''
Shen is optimistic about the trial, which is being conducted in double-blind fashion, meaning that half of the participants receive chemoembolization and Sorafenib, with the other half getting the standard treatment, chemoembolization, and a placebo.
"Both therapies by themselves have been shown to have some effect,'' Shen says. "So we're hoping the two treatments will be synergistic and will help these patients, who do not have curable disease, and that this will give them some meaningful prolongation of life. Liver cancer is one of the bad actors.''
Bert O'Neil, MD, a professor at the UNC Lineberger Comprehensive Cancer Center, is co-chair of the Cancer and Leukemia Group B, a national clinical research group that joined with the originator of the trial, the Eastern Cooperative Oncology Group.
"We're hoping that if we combine both chemoembolization and Sorafenib early on, rather than doing chemoembolization first and holding off on Sorafenib until the patient's disease is more advanced, we can get more bang for the buck,'' O'Neil says.
"At the early stages, this is a curable disease,'' O'Neil says. "But at least 80 percent of patients we see have a non-curable disease.''
A lack of early detection and the fact that liver cancer is extremely resistant to chemotherapy and radiation create a challenge, O'Neil says.
"We're in desperate need of new therapies, which is why clinical trials are so important for this type of cancer.''
Patients in the chemoembolization-Sorafenib trial will be followed for four years to track their progress, O'Neil says, with the goal of "keeping the disease in check at an earlier stage as long as possible."