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Chemotherapy

Sonoporation + Chemotherapy for Pancreatic Cancer

Philadelphia, PA

Phase 1 & 2

Recruiting

Led By Flemming Forsberg, PhD

Research Sponsored by Flemming Forsberg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically verified, locally advanced (nonresectable stage II/III) or metastatic (stage IV) adenocarcinoma of the pancreas

Patient must be >= 18 years old

Must not have

Patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment

Patients on life support or in a critical care unit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new method called sonoporation, which uses ultrasound and microbubbles, can increase the effectiveness of chemotherapy in treating pancreatic cancer.

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Who is the study for?

Adults over 18 with a new diagnosis of inoperable pancreatic cancer, visible on ultrasound, who can undergo standard chemotherapy. They must not be pregnant or breastfeeding and agree to use contraception. Participants should be relatively mobile (ECOG status 0-2) and have adequate blood counts and liver function.Check my eligibility

What is being tested?

The trial is testing sonoporation—a technique using ultrasound and microbubbles—combined with standard chemotherapy drugs for pancreatic cancer treatment. The goal is to see if this combination is more effective than chemotherapy alone.See study design

What are the potential side effects?

Potential side effects include reactions related to the contrast agent used in sonoporation, such as allergy-like symptoms, plus typical chemotherapy side effects like nausea, fatigue, low blood cell counts leading to increased infection risk, nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is an advanced or spread pancreatic cancer.

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I am 18 years old or older.

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I have been diagnosed with inoperable pancreatic cancer and will start standard chemotherapy.

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I can walk and care for myself with little to no help.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have advanced pancreatic cancer and severe liver issues.

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I am currently on life support or in a critical care unit.

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I have worsening chest pain due to heart artery blockage.

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I do not have uncontrolled heart rhythm problems.

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I have had pulmonary vasculitis or a history of blood clots in my lungs.

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I have severe lung disease or unstable heart/lung conditions.

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I do not have severe, uncontrolled heart failure.

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I require dialysis or have severe kidney problems.

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My liver is not working well, shown by specific blood test results.

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I have had a recent brain bleed.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Contrast enhanced ultrasound data

Number of chemotherapy cycles a subject can tolerate

Overall survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (sonazoid, ultrasound, chemotherapy)Experimental Treatment11 Interventions

Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel IV over 60 minutes on days 1, 8 and 15 OR FOLFIRINOX IV on days 1 and 2. Treatments repeat every 28 days for up to 3 cycles for gemcitabine and nab-paclitaxel, and every 14 days for up to 7 cycles for FOLFIRINOX in the absence of disease progression or unacceptable toxicity. Patients also receive sonazoid IV over 20 minutes and undergo CEUS. Patients undergo CT or PET/CT or MRI during screening and as clinically indicated on study.

Group II: Arm II (chemotherapy)Active Control9 Interventions

Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel IV over 60 minutes on days 1, 8 and 15 OR FOLFIRINOX IV on days 1 and 2. Treatments repeat every 28 days for up to 3 cycles for gemcitabine and nab-paclitaxel, and every 14 days for up to 7 cycles for FOLFIRINOX in the absence of disease progression or unacceptable toxicity. Patients undergo CT or PET/CT or MRI during screening and as clinically indicated on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2440

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180