Novel procedure minimizes side effects and toxicity while extending overall survival in patients with unresectable, locally advanced pancreatic cancer
May 22, 2023 – Miami Cancer Institute, part of Baptist Health South Florida, is currently enrolling participants in a Phase III clinical trial for patients with unresectable, locally advanced pancreatic cancer. The trial studies a novel delivery method for chemotherapy (gemcitabine) directly into the pancreatic tumor’s surroundings, thereby minimizing the toxicity and side effects of the treatment. The outpatient procedure delivers the chemotherapy intra-arterially using two balloons that are inflated next to the tumor, thereby avoiding the circulation of the chemotherapy to other parts of the body,
“The interim results of this trial, which we presented at this year’s AACR annual meeting, have been very promising,” said Antonio Ucar, M.D. an oncologist/hematologist at Miami Cancer Institute, who is leading the trial at the Center. “We saw that the procedure significantly minimized the side effects of the chemotherapy, which can be quite significant in the treatment of pancreatic cancer. Even more impressive is that we saw a significant increase in overall survival – 16 months among those who were in the experimental arm versus 10 months in the control arm of the study.”
All participants in the trial receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16-week treatment course until disease progression.
“This is a very interesting trial as it not only appears to lower side effects and toxicity, but it also increases the efficacy of the chemotherapy that is administered,” said Ripal Gandhi, M.D., a vascular interventional radiologist at Miami Cancer Institute, who is conducting the procedure. “Pancreatic tumors are usually surrounded by dense stromal tissue, which is difficult for chemotherapy to permeate. Administering gemcitabine intra-arterially, in between the two inflated balloons, increases the pressure head needed to push the chemotherapy across the blood vessel wall and directly into the tumor, allowing for a higher amount of chemotherapy to attack the tumor.”
This is a randomized trial, so patients who enroll may not be selected for the trial arm that is using the novel delivery method but instead continue on a gemcitabine plus nab-paclitaxel regimen. This Phase III trial has not concluded, meaning that results are interim and may change until conclusion. Outcomes vary by person and circumstance. More information about this trial and how to participate can be found here.