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Hyperthermia Treatment for Pancreatic Cancer

N/A
Recruiting
Led By Jason Molitoris, MD
Research Sponsored by NeoTherma Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2
Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab (-) HCV Ab (+) and HCV RNA (-)
Must not have
Concurrent active infection
Myocardial infarction <6 months ago
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trial uses a device to heat pancreatic tumors, improving blood flow and oxygen levels to make chemotherapy more effective. It targets adults with pancreatic cancer who are recommended for chemotherapy. The study aims to test the safety and functionality of this heating device.

Who is the study for?
Adults over 18 with confirmed pancreatic adenocarcinoma, including high-risk resectable or borderline cases based on NCCN guidelines. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and have proper organ function. Pregnant women are excluded, as well as those with certain heart conditions, blood pressure issues, metal implants incompatible with the device, recent major surgery or other investigational trials interference.
What is being tested?
The trial is testing VectRx Thermal Therapy combined with standard chemotherapy for pancreatic tumors. The therapy involves a device that heats the tumor to improve chemotherapy delivery. Participants will undergo this treatment four times before their scheduled chemo sessions in an early-stage study assessing safety and performance.
What are the potential side effects?
Potential side effects may include discomfort from heat application, skin irritation at the treatment site, changes in blood pressure during treatment due to heat exposure, and typical chemotherapy-related side effects such as nausea, fatigue, hair loss and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal based on creatinine levels or clearance.
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I don't have active hepatitis B or C.
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I am fully active or can carry out light work.
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I am older than 18 years.
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My cancer is a type of pancreatic cancer confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an active infection.
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I had a heart attack less than 6 months ago.
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I have pancreatitis.
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I need medication for heart failure or irregular heartbeat.
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I have severe nerve damage in my hands or feet.
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My blood pressure is either above 100 or below 50 mmHg despite medication.
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My lung function is severely reduced.
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I have hepatitis B with a viral load over 500 IU/mL.
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My blood pressure is either above 180 or below 90, even with medication.
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My cancer has worsened despite current treatment.
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My pancreatic cancer has come back after treatment.
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I cannot undergo MRI scans.
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I have had surgery or radiation for pancreatic cancer.
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I have had multiple strokes or a stroke less than 6 months ago.
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My cancer has spread to or is affecting my duodenum.
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I have HIV.
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I have severe chest pain due to heart issues, treated with medication.
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I have open skin wounds on my torso.
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I have a history of lung conditions like interstitial lung disease or sarcoidosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Performance of the VectRx device in its ability to increase temperature in the pancreas
Safety of the VectRx treatment evaluated by incidence of Adverse events (AEs) such as first and second-degree burns, edema and abdominal pain, will be assessed [safety and tolerability].

Trial Design

1Treatment groups
Experimental Treatment
Group I: VectRx Thermal TherapyExperimental Treatment1 Intervention
Device performance

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy and hyperthermia. Chemotherapy uses drugs to target and kill rapidly dividing cancer cells, but its effectiveness can be limited by poor blood flow to the tumor. Hyperthermia, which involves heating the tumor, can enhance chemotherapy by improving blood flow and making cancer cells more susceptible to the drugs. This combination is crucial for pancreatic cancer patients because the dense tissue and poor vascularization of pancreatic tumors often impede effective drug delivery.

Find a Location

Who is running the clinical trial?

DatabeanIndustry Sponsor
4 Previous Clinical Trials
327 Total Patients Enrolled
University of Maryland, BaltimoreOTHER
706 Previous Clinical Trials
378,434 Total Patients Enrolled
NeoTherma OncologyLead Sponsor

Media Library

VectRx Thermal Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05959395 — N/A
Pancreatic Cancer Research Study Groups: VectRx Thermal Therapy
Pancreatic Cancer Clinical Trial 2023: VectRx Thermal Therapy Highlights & Side Effects. Trial Name: NCT05959395 — N/A
VectRx Thermal Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05959395 — N/A
~2 spots leftby Oct 2025