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The role of sonoporation-enhanced treatment in patients with inoperable pancreatic cancer
EU CTIS ID: 2024-512176-35-00
What this study is testing
To evaluate the safety and efficacy of the combined Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX, and Sonazoid under ultrasound treatment, compared to Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX treatment alone.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma
- 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) an effective or highly effective birth control method
- Male patients with a female partner who is considered of childbearing potential, must agree to use a condom throughout the study and for 6 months after last exposure to the IMPs.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
- Patient must be ≥18 years old.
You likely can't join if
- Operable pancreatic cancer
- Patients that are allergic to any other component of Sonazoid.
- Patient is allergic to or intolerant of any IMPs included in the chemotherapy regimen that the patient is scheduled for (Gemcitabine/Nab-Paclitaxel or FOLFIRINOX).
- Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.
- Any reason why, in the opinion of the investigator, the patient should not participate.
- Patient is pregnant or is breast-feeding.
See the full eligibility criteria
- A new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma
- 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) an effective or highly effective birth control method
- Male patients with a female partner who is considered of childbearing potential, must agree to use a condom throughout the study and for 6 months after last exposure to the IMPs.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
- Patient must be ≥18 years old.
- Operable pancreatic cancer
- Patients that are allergic to any other component of Sonazoid.
- Patient is allergic to or intolerant of any IMPs included in the chemotherapy regimen that the patient is scheduled for (Gemcitabine/Nab-Paclitaxel or FOLFIRINOX).
- Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.
- Any reason why, in the opinion of the investigator, the patient should not participate.
- Patient is pregnant or is breast-feeding.
- 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
- Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
- Patient has a known history of HIV infection or active Hepatitis B or Hepatitis C infection.
- Patient requires dialysis or has severely impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 30 at the Screening Visit.
- Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the ULN) or Child Pugh Score C, at the Screening Visit
- 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 nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of Sonazoid).
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.