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A Single-center, Prospective, Non-randomized, Open, Pilot Study Evaluating the Safety and Performance of the Extroducer® Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients with Unresectable Locally Advanced Pancreatic Cancer
EU CTIS ID: 2025-524733-11-00
What this study is testing
To estimate the Safety of the Extroducer® Infusion Catheter System to administer drug or therapeutic solution into the peri/extravascular area of the peripheral vasculature.
- Phase I and Phase II (Integrated)- Other
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
- Able to comply with scheduled visits, treatment plan, able to undergo catheterization, imaging procedures, laboratory tests, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- Have acceptable organ and marrow function as defined below: i. Absolute neutrophil count (ANC) ≥ 1500 cells/mm³ (1.5x109 cells/L) ii. Hemoglobin ≥ 9.0 g/dL iii. Platelets ≥ 100,000/µL iv. Total bilirubin ≤ 2 × upper limit of normal (ULN). v. AST (Aspartate Aminotransferase) ≤ 3 × ULN. vi. ALT (Alanine Aminotransferase) ≤ 3 × ULN vii. Creatinine Within 1.5 x ULN OR Creatinine clearance ≥ 60 mL/min for patients with creatinine levels above 1.5 x ULN.
- Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and must agree to use a medically acceptable contraception from enrollment until final treatment of Gemcitabine.
- Male subjects who are planning to father a child (i.e., planning a pregnancy with a partner) during the clinical investigation. i. Male subjects must agree to use highly effective contraception with female partners of childbearing potential during the clinical investigation and for 3 months after the last dose of Gemcitabine and must not donate sperm during this period. ii. Acceptable methods include: combined hormonal contraception, progestogen-only contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion in the female partner, or vasectomy of the male participant (confirmed azoospermia) plus an additional barrier method as required by local regulations. iii. Sexual abstinence is acceptable only if it is the subject’s usual and preferred lifestyle; periodic abstinence and withdrawal are not acceptable.
- Voluntarily agrees to participate and has duly singed the Informed Consent Form.
- Age 18 years or older.
You likely can't join if
- Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement.
- Unmanaged concurrent illnesses, encompassing psychiatric conditions or challenging social circumstances, that, as per the investigator's judgment, could undermine compliance to the study protocols or pose an unacceptable risk to the patient.
- Pregnant or nursing individuals.
- Inability to consent.
- Pancreatic tumor is different from adenocarcinoma (e.g., neuroendocrine, metastases). Adenosquamous is allowed.
- Cancer has spread to other organs or non-regional lymph nodes (Metastases).
See the full eligibility criteria
Who can join
- Able to comply with scheduled visits, treatment plan, able to undergo catheterization, imaging procedures, laboratory tests, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- Have acceptable organ and marrow function as defined below: i. Absolute neutrophil count (ANC) ≥ 1500 cells/mm³ (1.5x109 cells/L) ii. Hemoglobin ≥ 9.0 g/dL iii. Platelets ≥ 100,000/µL iv. Total bilirubin ≤ 2 × upper limit of normal (ULN). v. AST (Aspartate Aminotransferase) ≤ 3 × ULN. vi. ALT (Alanine Aminotransferase) ≤ 3 × ULN vii. Creatinine Within 1.5 x ULN OR Creatinine clearance ≥ 60 mL/min for patients with creatinine levels above 1.5 x ULN.
- Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and must agree to use a medically acceptable contraception from enrollment until final treatment of Gemcitabine.
- Male subjects who are planning to father a child (i.e., planning a pregnancy with a partner) during the clinical investigation. i. Male subjects must agree to use highly effective contraception with female partners of childbearing potential during the clinical investigation and for 3 months after the last dose of Gemcitabine and must not donate sperm during this period. ii. Acceptable methods include: combined hormonal contraception, progestogen-only contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion in the female partner, or vasectomy of the male participant (confirmed azoospermia) plus an additional barrier method as required by local regulations. iii. Sexual abstinence is acceptable only if it is the subject’s usual and preferred lifestyle; periodic abstinence and withdrawal are not acceptable.
- Voluntarily agrees to participate and has duly singed the Informed Consent Form.
- Age 18 years or older.
- Histologically confirmed, locally advanced pancreatic cancer.
- Systemic treatment with IV chemotherapy for at least six months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The target tumor is a measurable tumor according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 prior to initiating Extroducer® Gemcitabine treatment.
- Stable disease or locally progressive disease without signs of metastatic disease as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose.
- Locally Advanced Pancreatic Cancer not amenable to resection as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose.
What rules you out
- Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement.
- Unmanaged concurrent illnesses, encompassing psychiatric conditions or challenging social circumstances, that, as per the investigator's judgment, could undermine compliance to the study protocols or pose an unacceptable risk to the patient.
- Pregnant or nursing individuals.
- Inability to consent.
- Pancreatic tumor is different from adenocarcinoma (e.g., neuroendocrine, metastases). Adenosquamous is allowed.
- Cancer has spread to other organs or non-regional lymph nodes (Metastases).
- Unknown stage or recurrent pancreatic cancer.
- Patient contraindication to Gemcitabine treatments.
- Patients in which iodine contrast is contraindicated.
- Presence of structures that impede tumor access.
- Concurrent or prior malignancy unless disease-free for ≥3 years, with exceptions for nonmelanoma skin cancer, carcinoma in situ of the cervix or bladder, or Gleason Grade < 7 organ-confined prostate cancer. This may be subject to investigator’s judgement based on individual patient circumstances and the nature of the malignancy.
The study team makes the final eligibility decision.
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.
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.