Chemotherapy can save lives, but for many patients the side effects can be brutal.

A targeted drug-delivery system from RenovoRx is being studied as a way to send chemotherapy directly near a pancreatic tumor, instead of through the entire body. The system, called Trans-Arterial Micro-Perfusion, or TAMP, is in a Phase III clinical trial for locally advanced pancreatic cancer.

For 83-year-old Hernando Salcedo, who had struggled with nausea, weakness and exhaustion during standard chemotherapy, the trial at Miami Cancer Institute brought relief.

“The difference was tremendous,” Hernando said, according to Fox News. “I completed eight sessions, one every 15 days, and I felt dramatically better than I did with the original chemotherapy.”

RenovoRx’s platform uses the FDA-cleared RenovoCath device to deliver chemotherapy through a catheter placed in an artery near the tumor. A physician guides the catheter using X-ray imaging.

Shaun Bagai, CEO of RenovoRx, said the platform is designed to localize chemotherapy delivery near the tumor instead of relying on the drug to travel through the whole body.

“Once in position, two small balloons on the catheter are inflated, and the system is adjusted to isolate a targeted segment of artery adjacent to a tumor,” Bagai said. “The chemotherapy drug is then infused between the balloons, creating pressure to push the drug across the vessel wall and near the tumor, directly bathing the target tumor.”

Bagai said the procedure is typically done in an outpatient setting and does not usually require general anesthesia.

“The procedure itself is minimally invasive and is typically performed in an outpatient setting without the need for patients to be put under general anesthesia,” Bagai said.

Dr Ripal Gandhi, a vascular interventional radiologist and interventional oncologist at Baptist Health Miami Cardiac & Vascular Institute and Miami Cancer Institute, said standard IV chemotherapy affects healthy cells as well as cancer cells.

“With IV chemotherapy, the drug travels through the bloodstream, affecting both cancerous and healthy cells, which can lead to side effects,” Dr Gandhi said.

He said pancreatic cancer is particularly difficult to treat because little of the drug may actually reach the tumor.

“Studies have shown that less than 10 percent of chemotherapy administered intravenously actually reaches tumor cells due to the few blood vessels in the tumor as well as dense fibrous stroma, which serves as a physical barrier in the tumor microenvironment,” Dr Gandhi said.

Dr Gandhi said TAMP does not depend on chemotherapy circulating through the body to reach the tumor.

“This targeted approach via TAMP does not rely on chemotherapy circulating through the body to carry the drug to the tumor via tumor feeder vessels,” Dr Gandhi said. “Trans-arterial micro-perfusion is a drug-delivery platform that delivers chemotherapy directly near the target tumor where it is needed most.”

He compared it to “a drip irrigation system for individual plants instead of watering an entire lawn.”

Hernando said he was diagnosed with locally advanced pancreatic cancer after going to the doctor with a swollen stomach and hip pain. He started standard chemotherapy in August 2015 and said the side effects were severe.

“My body was going through an incredible amount of stress,” Hernando said. “My stomach was inflamed, I had persistent pain in my head, and I had almost no energy.”

He said he was also receiving chemotherapy and radiation at the same time.

“It was a very difficult period, both physically and emotionally,” he said. “I remember feeling exhausted, overwhelmed and unsure of what the future would look like.”

When doctors offered the targeted treatment option, he said it felt like a turning point.

“To me, it felt like a new opportunity to live,” he said. “It gave me hope at a time when my family and I really needed it.”

He said his condition improved after the switch.

“Before, I was losing weight, had no appetite and felt drained,” Hernando said. “After switching treatments, things began to change. I stopped losing weight, my appetite came back, my color improved and I had more energy.”

“After about eight weeks, we could see real progress,” Hernando said. “I was eating more, moving more and feeling excited about life again.”

One of the clearest signs of that change came at a family wedding.

“That moment meant everything to me,” he said. “After everything I had been through, being able to celebrate with my family in that way felt like a gift.”

“That night at the wedding, I was not thinking only about cancer or treatment,” Hernando said. “I was living.”

Dr Gandhi said completed clinical studies with TAMP in pancreatic cancer showed “a potential for better outcomes and less side effects for patients.”

He said an interim analysis from the Phase III TIGeR-PaC trial showed encouraging signs.

“In the initial interim analysis of the TIGeR-PaC clinical trial, there was a trend towards improved overall survival by 6 months and improvement in the progression free survival by 8.1 months with 65 percent fewer adverse events in the TAMP arm of the study,” Dr Gandhi said.

Dr Gandhi said the treatment is not for every patient. He said it may suit people whose pancreatic cancer cannot be removed with surgery but has not spread to other organs.

“He is precisely the type of patient who would benefit best from this approach because he has a tumor which is too far advanced to be treated surgically, but it has not spread to other organs,” Dr Gandhi said of Hernando.

He said clinical trials are an important option for pancreatic cancer patients.

“I discussed with him that the recommendation of the National Comprehensive Cancer Network is that the best management for pancreatic cancer patients is participation in a clinical trial whenever possible and he was an ideal candidate,” Dr Gandhi said.

Dr Gandhi also said TAMP may be an option before, during or after other treatments, including IV chemotherapy or radiation.

“TAMP can be used at any point within the treatment landscape, before, during or after other treatment modalities such as IV chemotherapy or radiation,” he said.

RenovoRx said enrollment in the TIGeR-PaC Phase III trial is expected to be completed in mid-2026, with final results expected in 2027.

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