Trial to test new approach for treating inoperable pancreatic cancer

To improve outcomes for patients living with inoperable pancreatic cancer, researchers from MUSC Hollings Cancer Center are participating in a multisite Phase III clinical trial, testing a new approach for delivering chemotherapy.

The approach uses a thin, flexible tube called a catheter to deliver chemotherapy drugs directly into the pancreas through a patient’s arteries, allowing for a targeted approach that could be more effective in shrinking and stabilizing certain types of tumors.

Previous trials testing the safety of this approach found that median survival rates for patients with locally advanced pancreatic adenocarcinoma nearly doubled from 14 months to 28 months. The method was also tolerated better by patients, who experienced fewer side effects from the drug due to less of it being released into the rest of the body.

Thor Johnson, M.D., Ph.D., lead investigator for Hollings’ portion of the trial and associate professor in the Department of Radiology and Radiological Sciences at the Medical University of South Carolina, has seen the potential effects of the catheter-directed approach in his own patients and has high hopes for the trial’s results.

“I personally down-staged a patient from unresectable disease to being able to remove his cancer through surgery. He is still doing well two-and-a-half years later,” said Johnson. “Given that this is an invasive procedure, however, we want to make certain that this is validated in a randomized fashion in order to address whether this should be standard of care.”

A deadly and aggressive cancer

Pancreatic cancer is the third most common cause of cancer deaths in both the U.S. and South Carolina, killing more than 47,000 Americans and 800 South Carolina residents annually. Pancreatic adenocarcinoma – which is what this trial is targeting – is the most common type, accounting for 85% of cases.

This type often goes undetected until it has advanced to a late stage, leaving these patients with poor prognoses. Only 24% of people survive one year, and only 9% live five years or longer.

For patients with inoperable tumors, the current standard of care is to deliver radiation and chemotherapy through an IV – a combination that can prolong patients’ survival but ultimately doesn’t improve their quality of life. It’s also associated with burdensome side effects that can leave patients feeling worse.

In this trial, nicknamed the TIGeR-PaC trial, all patients will receive the current standard of radiation and IV chemotherapy for approximately four months. Those who remain eligible will then be randomized to either continuing the current standard treatment or beginning the catheter-directed approach for up to 16 weeks or until disease progression.

The researchers will measure the approach’s effectiveness by analyzing overall survival rates within three years. They’ll also examine the amount of time a patient lives without disease progression, the response rate to the new approach, quality of life and symptoms.

Hope for the future

The trial will enroll more than 300 patients across 40 sites in the U.S. and Europe. To be eligible, patients must have received a diagnosis of locally advanced pancreatic cancer that has not progressed to other parts of the body and must have a life expectancy of greater than 12 weeks. Their disease must also be newly diagnosed and not previously treated.

Based on results from the study’s first two phases, Johnson is hopeful the approach will be proved effective and widely adopted as a new and improved treatment option for patients living with this aggressive disease. He’s excited to be on the forefront of new discoveries, allowing Hollings patients access to the latest treatments even before they’re made available elsewhere.

“We want our patients to have access to all of the available treatments for their cancer, and this is a new one that I want them to be able to access without having to go to another medical center,” said Johnson. “From my personal experience with the catheter and the extraordinary data from the first trial, I would be surprised if this is not standard of care in five years for this indication.”

This research is supported by RenovoRx.

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