Locally Advanced Pancreatic Ductal AdenocarcinomaPhase 1/2NCT04821284
Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer
A Phase 1/2 study testing Gemcitabine Hydrochloride, Nab-paclitaxel and Fluorouracil in people with Locally Advanced Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, run by Flemming Forsberg at 2 sites in 2 countries.
Trial summary
This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer. Sonoporation is a novel method that uses ultrasound and microbubbles to increase therapeutic effect by increasing uptake or enhance sensitization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8
- What is being tested?
- Gemcitabine Hydrochloride, Nab-paclitaxel and Fluorouracil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Dec 2021to 28 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be >= 18 years old
- Patient has a new diagnosis of PDAC and is scheduled to undergo SoC chemotherapy
- (International Classification of Diseases [ICD]-10 C25.0 Malignant neoplasm: Head of pancreas, C25.1: Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas, C25.3 Malignant neoplasm: Pancreatic duct and C25.9 Malignant neoplasm: Pancreas, unspecified). Any ICD-10 code in the C25 section (malignant neoplasm of pancreas) will be acceptable
- Histologically verified, locally advanced (stage II/III) or metastatic (stage IV) adenocarcinoma of the pancreas
- The PDAC must be visible on grayscale ultrasound prior to injection of ultrasound contrast
- Must be ambulatory with an ECOG performance status between 0 and 2
Show all 9Show fewer
- Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun > 15 days prior to the screening visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomized partner (6 months minimum). Male patients must also agree to practice throughout the study an approved method of birth control.
- (Note: To be considered NOT of child-bearing potential, female patients must be postmenopausal [with amenorrhea for at least 2 years prior to study entry] or surgically sterile [bilateral tubal ligation at least 6 months prior to study entry, or of a hysterectomy and/or bilateral oophorectomy])
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), and national/local regulations
Who cannot join
- Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug
- Patient has severe chronic obstructive pulmonary disease, or pulmonary hypertension or unstable cardiopulmonary conditions
- Patients who are medically unstable. For example:
- Patients on life support or in a critical care unit
- Patients with unstable occlusive disease (e.g., crescendo angina)
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
Show all 17Show fewer
- Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
- Patients with recent cerebral hemorrhage
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study in the opinion of the investigator
- Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine >= 1.5 x ULN or calculated creatinine clearance < 45 mL/min at the screening visit
- Patient has severe impairment of liver function, defined as a serum albumin level =< 25 g/L and/or a prothrombin time international normalized ratio (INR) > 2.3 (or activated partial thromboplastin time [APTT] > 6 seconds above the upper limit of normal), or a Child Pugh Score C at the screening visit
- Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)
- Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with non anaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour following the administration of Sonazoid)
- Patients that are allergic to any other component of Sonazoid
- Any reason why, in the opinion of the investigator, the patient should not participate
- Patient is pregnant or is breast-feeding
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Optimizing Ultrasound Enhanced Delivery of Therapeutics
This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer. Sonoporation is a novel method that uses ultrasound and microbubbles to increase therapeutic effect by increasing uptake or enhance sensitization. Sonoporation together with chemotherapy may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and therapeutic efficacy of sonoporation on pancreatic ductal adenocarcinoma (PDAC) standard of care (SoC) treatment based on local progression-free and overall survival with the main endpoint being an increase in median progression-free survival of subjects by 8.7 months in the sonoporation group relative to controls.
SECONDARY OBJECTIVES:
- To evaluate the effect of sonoporation on the median time to treatment failure (TTF) (in percent).
II. To evaluate the effect of sonoporation on the number of chemotherapy cycles subjects can undergo.
III. To evaluate the effect of sonoporation on tumor volume measured by clinical diagnostic ultrasound.
IV. To evaluate the effect of sonoporation on tumor perfusion using contrast enhanced ultrasound (CEUS) - specifically harmonic imaging (HI) and subharmonic imaging (SHI).
- To evaluate the effect of sonoporation on tumor interstitial fluid pressures using subharmonic aided pressure estimation (SHAPE).
VI. To evaluate the effect of sonoporation on tumor volume using clinical diagnostic computed tomography (CT).
VII. To evaluate the effect of sonoporation on tumor stiffness using clinical ultrasound shear wave elastography (SWE).
VIII. To evaluate the effect of sonoporation on serum CA 19-9 concentrations. IX. Clinical benefit response, which is a measure of clinical improvement based on analgesic consumption, Eastern Cooperative Oncology Group (ECOG) performance status, and weight change.
- To evaluate the effect of sonoporation on patient quality of life.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel intravenously (IV) over 60 minutes on days 1, 8 and 15 OR fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (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 computed tomography (CT) or positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) during screening and as clinically indicated on study.
ARM II: 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.
After completion of study treatment, patients are followed up every 3 months.
- Conditions
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8, Stage IIB Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
- Being tested
- Gemcitabine Hydrochloride, Nab-paclitaxel, Fluorouracil, Irinotecan Hydrochloride, Leucovorin Calcium
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called 1-(2-Oxo-4-amino-1, 2-dihydropyrimidin-1-yl)-2-deoxy-2, 2-difluororibose, hydrochloride, 122111-03-9
Given IV
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel
Given IV
FluorouracilDrug
Also called 2,4-Dioxo-5-fluoropyrimidine, 5 Fluorouracil, 5 FU, 5 Fluorouracilum
Given IV
Also called 136572-09-3, Campto, Camptosar, Camptothecin 11
Given IV
Also called 1492-18-8, 5-Formyl Tetrahydrofolate, 5-Formyl-5,6,7,8-tetrahydrofolic Acid, 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic Acid
Given IV
OxaliplatinDrug
Also called 1-OHP, 61825-94-3, [(1R,-2R)-1,2-cyclohexanediamine-N,N'][oxalato (2--)-O,O']platinum, [SP-4-2-(1R-trans)]-(1,2,cyclohexanediamine-N
Given IV
Perflubutane MicrobubbleOther
Oxaliplatin
Contrast-Enhanced UltrasoundProcedure or surgery
Undergo CEUS
Quality-of-Life AssessmentOther
Ancillary studies
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT or PET/CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Arm I (sonazoid, ultrasound, chemotherapy) | Experimental | 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. Receives: Drug: Gemcitabine Hydrochloride; Drug: Nab-paclitaxel; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Other: Perflubutane Microbubble; Procedure: Contrast-Enhanced Ultrasound; Other: Quality-of-Life Assessment; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
| Arm II (chemotherapy) | Active comparator | 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. Receives: Drug: Gemcitabine Hydrochloride; Drug: Nab-paclitaxel; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Other: Quality-of-Life Assessment; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Gehan-Breslow-Wilcoxon test and Log-rank (Mantel-Cox) test will be used to compare progression free survival (PSF) between the groups with and without sonoporation.
Measured: Up to 3 years
Secondary outcomes (5)
Number of chemotherapy cycles a subject can tolerate
Gehan-Breslow-Wilcoxon test and Log-rank (Mantel-Cox) test will be used to compare number of chemotherapy cycles between the groups with and without sonoporation.
Measured: Up to 3 years
Overall survival
Gehan-Breslow-Wilcoxon test and Log-rank (Mantel-Cox) test will be used to compare overall survival (PSF) between the groups with and without sonoporation.
Measured: Up to 3 years
Tumor volume changes
Relative changes will be measured with ultrasound, computed tomography and/or magnetic resonance imaging and will also be compared between the groups with and without sonoporation.
Measured: Up to 3 years
Contrast enhanced ultrasound data
Will provide perfusion and pressure estimates, which will be compared (individually and jointly) to subject outcomes in the groups with and without sonoporation as determined by the medical oncology team.
Measured: Up to 3 years
Tumor stiffness
Will be measured as shear wave velocity obtained by ultrasound shear wave elastography and will be compared between the groups with and without sonoporation.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start6 Dec 2021
- Primary completion31 Oct 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flemming Forsberg
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Flemming Forsberg, Thomas Jefferson University
- Investigators
- Flemming Forsberg, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821284
- Sponsor's protocol ID
- 20F.1207
- Other IDs
- R01CA199646, JT 15477
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2021
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Adler O, Machado P, Vu T, Forsberg F, Gilja OH, Adam D. Perfusion Assessment in CEUS Imaging for Estimating Pancreatic Cancer Response to Sonoporation-Enhanced Chemotherapy. Ultrason Imaging. 2026 Jan;48(1):36-52. doi: 10.1177/01617346251367758. Epub 2025 Oct 24.
PubMed 41133726
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Ultrasound Enhanced Delivery of Therapeutics
- ClinicalTrials.gov ID
- NCT04821284
- Acronym / sponsor ID
- 20F.1207
- Conditions
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8, Stage IIB Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Flemming ForsbergUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer. Sonoporation is a novel method that uses ultrasound and microbubbles to increase therapeutic effect by increasing uptake or enhance sensitization. Sonoporation together with chemotherapy may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and therapeutic efficacy of sonoporation on pancreatic ductal adenocarcinoma (PDAC) standard of care (SoC) treatment based on local progression-free and overall survival with the main endpoint being an increase in median progression-free survival of subjects by 8.7 months in the sonoporation group relative to controls.
SECONDARY OBJECTIVES:
- To evaluate the effect of sonoporation on the median time to treatment failure (TTF) (in percent).
II. To evaluate the effect of sonoporation on the number of chemotherapy cycles subjects can undergo.
III. To evaluate the effect of sonoporation on tumor volume measured by clinical diagnostic ultrasound.
IV. To evaluate the effect of sonoporation on tumor perfusion using contrast enhanced ultrasound (CEUS) - specifically harmonic imaging (HI) and subharmonic imaging (SHI).
- To evaluate the effect of sonoporation on tumor interstitial fluid pressures using subharmonic aided pressure estimation (SHAPE).
VI. To evaluate the effect of sonoporation on tumor volume using clinical diagnostic computed tomography (CT).
VII. To evaluate the effect of sonoporation on tumor stiffness using clinical ultrasound shear wave elastography (SWE).
VIII. To evaluate the effect of sonoporation on serum CA 19-9 concentrations. IX. Clinical benefit response, which is a measure of clinical improvement based on analgesic consumption, Eastern Cooperative Oncology Group (ECOG) performance status, and weight change.
- To evaluate the effect of sonoporation on patient quality of life.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel intravenously (IV) over 60 minutes on days 1, 8 and 15 OR fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (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 computed tomography (CT) or positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) during screening and as clinically indicated on study.
ARM II: 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.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (sonazoid, ultrasound, chemotherapy) | Experimental | Drug: Gemcitabine Hydrochloride, Drug: Nab-paclitaxel, Drug: Fluorouracil, Drug: Irinotecan Hydrochloride, Drug: Leucovorin Calcium, Drug: Oxaliplatin, Other: Perflubutane Microbubble, Procedure: Contrast-Enhanced Ultrasound, Other: Quality-of-Life Assessment, Procedure: Computed Tomography, Procedure: Magnetic Resonance ImagingPatients 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. |
| Arm II (chemotherapy) | Active comparator | Drug: Gemcitabine Hydrochloride, Drug: Nab-paclitaxel, Drug: Fluorouracil, Drug: Irinotecan Hydrochloride, Drug: Leucovorin Calcium, Drug: Oxaliplatin, Other: Quality-of-Life Assessment, Procedure: Computed Tomography, Procedure: Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be >= 18 years old
- Patient has a new diagnosis of PDAC and is scheduled to undergo SoC chemotherapy
- The PDAC must be visible on grayscale ultrasound prior to injection of ultrasound contrast
- Must be ambulatory with an ECOG performance status between 0 and 2
- Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun > 15 days prior to the screening visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomized partner (6 months minimum). Male patients must also agree to practice throughout the study an approved method of birth control.
Key exclusion criteria (17 listed)
- Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug
- Patient has severe chronic obstructive pulmonary disease, or pulmonary hypertension or unstable cardiopulmonary conditions
- Patients who are medically unstable. For example:
- Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study in the opinion of the investigator
- Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine >= 1.5 x ULN or calculated creatinine clearance < 45 mL/min at the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine HydrochlorideAlso: 1-(2-Oxo-4-amino-1, 2-dihydropyrimidin-1-yl)-2-deoxy-2, 2-difluororibose, hydrochloride, 122111-03-9Given IV | Drug | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| Nab-paclitaxelAlso: ABI 007, ABI-007, Abraxane, Albumin-bound PaclitaxelGiven IV | Drug | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| FluorouracilAlso: 2,4-Dioxo-5-fluoropyrimidine, 5 Fluorouracil, 5 FU, 5 FluorouracilumGiven IV | Drug | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| Irinotecan HydrochlorideAlso: 136572-09-3, Campto, Camptosar, Camptothecin 11Given IV | Drug | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| Leucovorin CalciumAlso: 1492-18-8, 5-Formyl Tetrahydrofolate, 5-Formyl-5,6,7,8-tetrahydrofolic Acid, 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic AcidGiven IV | Drug | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| OxaliplatinAlso: 1-OHP, 61825-94-3, [(1R,-2R)-1,2-cyclohexanediamine-N,N'][oxalato (2--)-O,O']platinum, [SP-4-2-(1R-trans)]-(1,2,cyclohexanediamine-NGiven IV | Drug | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| Perflubutane MicrobubbleOxaliplatin | Other | Arm I (sonazoid, ultrasound, chemotherapy) |
| Contrast-Enhanced UltrasoundUndergo CEUS | Procedure or surgery | Arm I (sonazoid, ultrasound, chemotherapy) |
| Quality-of-Life AssessmentAncillary studies | Other | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT or PET/CT | Procedure or surgery | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical ImagingUndergo MRI | Procedure or surgery | Arm I (sonazoid, ultrasound, chemotherapy), Arm II (chemotherapy) |
Primary outcome
Progression-free survival
Time frame: Up to 3 years
Gehan-Breslow-Wilcoxon test and Log-rank (Mantel-Cox) test will be used to compare progression free survival (PSF) between the groups with and without sonoporation.
5 secondary outcomes
Number of chemotherapy cycles a subject can tolerate
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
Tumor volume changes
Time frame: Up to 3 years
Contrast enhanced ultrasound data
Time frame: Up to 3 years
Tumor stiffness
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Derived from this study: PubMed 41133726Adler O, Machado P, Vu T, Forsberg F, Gilja OH, Adam D. Perfusion Assessment in CEUS Imaging for Estimating Pancreatic Cancer Response to Sonoporation-Enhanced Chemotherapy. Ultrason Imaging. 2026 Jan;48(1):36-52. doi: 10.1177/01617346251367758. Epub 2025 Oct 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Forsberg, PhD principal investigator
Thomas Jefferson University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine Hydrochloride, Nab-paclitaxel and Fluorouracil in people with Locally Advanced Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, run by Flemming Forsberg at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.