Pancreatic Cancer Non-resectablePhase 1/2NCT07575191
Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer
A Phase 1/2 study testing Gemcitabine and Extroducer Infusion Catheter System in people with Pancreatic Cancer Non-resectable, run by Smartwise Sweden AB at 1 site in Sweden.
Trial summary
This study is testing a new way to deliver the chemotherapy drug Gemcitabine in pancreatic tumors using the catheter Extroducer® Infusion Catheter System. The study will include patients with Locally Advanced Pancreatic Cancer that cannot be removed with surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- Gemcitabine and Extroducer Infusion Catheter System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSweden
- Study dates
- 29 Apr 2026to Jun 2028
- 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
- 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.
- 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.
Show all 16Show fewer
- 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.
- Have acceptable organ and marrow function as defined below:
- 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 and highly effective contraception from enrollment until 6 months after final study treatment of Gemcitabine.
- Male subjects who are planning to father a child (i.e., planning a pregnancy with a partner) during the clinical investigation.
- 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.
- Acceptable methods include: a condom in addition to 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).
- Sexual abstinence is acceptable only if it is the subject's usual and preferred lifestyle; periodic abstinence and withdrawal are not acceptable.
Who cannot join
- Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement.
- 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.
Show all 11Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Solna, 171 64
Maximilian Kordes, MD, PhD, +46 (0)8-123 70000, nextgem.trial@gmail.com
About this study
Official title: 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
This study is testing a new way to deliver the chemotherapy drug Gemcitabine in pancreatic tumors using the catheter Extroducer® Infusion Catheter System. The study will include patients with Locally Advanced Pancreatic Cancer that cannot be removed with surgery.
Patients will receive four treatment sessions, given every two weeks, in which Gemcitabine is infused directly into or near the tumor. The study will test up to three increasing dose levels of Gemcitabine (200 mg, 400 mg, and 100 mg).
Read more
The study will enroll three groups of three patients each. After each group completes treatment, an independent safety committee will review the results to decide whether it is safe to move to the next dose per predefined study criteria.
After finishing treatment, patients will be followed for six months. Each patient's total participation in the study will last about 8-9 months. The main goal of the study is to evaluate the safety and feasibility of this treatment approach.
Read the detailed description
This is a prospective, interventional, non-randomized, open-label pilot study designed to evaluate the safety and performance of the Extroducer® Infusion Catheter System for peri- and intratumoral delivery of Gemcitabine in patients with unresectable Locally Advanced Pancreatic Cancer (LAPC).
The study uses a dose-escalation design with three sequential cohorts to assess the feasibility and safety of repeated peri-/intratumoral Gemcitabine infusions at dose levels of 100 mg, 200 mg, and 400 mg.
Each patient is planned to receive four study treatment sessions administered every two weeks. Following completion of the treatment phase, patients will be followed for 6 months until study completion. The total study participation per patient is expected to be approximately 8-9 months.
Each cohort will include three patients. After completion of study treatment by all patients in a cohort, the Data Safety Monitoring Board (DSMB) will review safety data and determine whether dose escalation is appropriate based on the occurrence of study-defined dose-limiting toxicities (DLTs), and will recommend the dose level for the next cohort.
A total of nine eligible participants are planned to be enrolled at one study site in Sweden.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Gemcitabine, Extroducer Infusion Catheter System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine administered via the Extroducer Infusion Catheter System for targeted delivery.
Extroducer Infusion Catheter SystemDevice
Infusion catheter system for delivery of diagnostic or therapeutic agents into the extravascular space or peripheral vasculature.
| Study group | Role | What they receive |
|---|---|---|
| Sequential targeted Gemcitabine delivery | Experimental | Participants receive Gemcitabine administered via the Extroducer® Infusion Catheter System for targeted intra-arterial delivery, according to a predefined sequential treatment protocol. Receives: Drug: Gemcitabine; Device: Extroducer Infusion Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extroducer® related Serious Adverse Events
Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.
Measured: From each study treatment until 72 hours post treatment.
Secondary outcomes (8)
Gemcitabine related Serious Adverse Events
Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion.
Measured: From first study treatment on Day 0 until study completion, ~8 Months.
Overall Survival
Overall Survival (OS) at 6 months after final Extroducer® treatment infusion with Gemcitabine.
Measured: Through study completion, ~8 Months.
Progression Free Survival
Progression Free Survival (PFS) at 6 months after final Extroducer® treatment infusion with Gemcitabine.
Measured: Through study completion, ~8 Months.
Tumor resectability
Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine.
Measured: Through study completion, ~8 Months.
Tumor response
Classification of tumor response according to RECIST before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine.
Measured: Through study completion, ~8 Months.
Tumor marker
Evaluation of the tumor marker CA-19-9 before (baseline) and after (Visits 9, 11-13) Extroducer® treatment infusion with Gemcitabine.
Measured: Through study completion, ~8 Months.
Patient Quality of Life
Evaluation of subjects' quality of life using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items) and EORTC PAN26 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26) questionnaires before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine.
All scales and single-item measures are scored from 1 to 100. Higher scores indicate a higher level of the measured construct. For functional scales, a higher score represents better or healthier functioning. A higher score on the Global Health Status/Quality of Life scale indicates better quality of life, whereas a higher score on symptom scales or items reflects a greater level of symptoms or problems.
The two questionnaires are intended to be used together as a single module and therefore constitute one combined outcome measure.
Measured: Through study completion, ~8 Months.
Incidence of Adverse Events and Device Deficiencies
The incidence, severity, and seriousness of Adverse Events and Device Deficiencies throughout the clinical investigation.
Measured: Through study completion, ~8 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start29 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smartwise Sweden AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575191
- Sponsor's protocol ID
- nEXT-GEM
- Other IDs
- 2025-524733-11-00, 25-10-054715, 2025
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) are not planned to be shared. Study results will be reported in aggregate form through peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07575191
- Acronym / sponsor ID
- nEXT-GEM
- Conditions
- Pancreatic Cancer Non-resectable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Smartwise Sweden ABIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 May 2026 (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 study is testing a new way to deliver the chemotherapy drug Gemcitabine in pancreatic tumors using the catheter Extroducer® Infusion Catheter System. The study will include patients with Locally Advanced Pancreatic Cancer that cannot be removed with surgery.
Patients will receive four treatment sessions, given every two weeks, in which Gemcitabine is infused directly into or near the tumor. The study will test up to three increasing dose levels of Gemcitabine (200 mg, 400 mg, and 100 mg).
The study will enroll three groups of three patients each. After each group completes treatment, an independent safety committee will review the results to decide whether it is safe to move to the next dose per predefined study criteria.
After finishing treatment, patients will be followed for six months. Each patient's total participation in the study will last about 8-9 months. The main goal of the study is to evaluate the safety and feasibility of this treatment approach.
Detailed description
This is a prospective, interventional, non-randomized, open-label pilot study designed to evaluate the safety and performance of the Extroducer® Infusion Catheter System for peri- and intratumoral delivery of Gemcitabine in patients with unresectable Locally Advanced Pancreatic Cancer (LAPC).
The study uses a dose-escalation design with three sequential cohorts to assess the feasibility and safety of repeated peri-/intratumoral Gemcitabine infusions at dose levels of 100 mg, 200 mg, and 400 mg.
Each patient is planned to receive four study treatment sessions administered every two weeks. Following completion of the treatment phase, patients will be followed for 6 months until study completion. The total study participation per patient is expected to be approximately 8-9 months.
Each cohort will include three patients. After completion of study treatment by all patients in a cohort, the Data Safety Monitoring Board (DSMB) will review safety data and determine whether dose escalation is appropriate based on the occurrence of study-defined dose-limiting toxicities (DLTs), and will recommend the dose level for the next cohort.
A total of nine eligible participants are planned to be enrolled at one study site in Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential targeted Gemcitabine delivery | Experimental | Drug: Gemcitabine, Device: Extroducer Infusion Catheter SystemParticipants receive Gemcitabine administered via the Extroducer® Infusion Catheter System for targeted intra-arterial delivery, according to a predefined sequential treatment protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement.
- 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.
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 |
|---|---|---|
| GemcitabineGemcitabine administered via the Extroducer Infusion Catheter System for targeted delivery. | Drug | Sequential targeted Gemcitabine delivery |
| Extroducer Infusion Catheter SystemInfusion catheter system for delivery of diagnostic or therapeutic agents into the extravascular space or peripheral vasculature. | Device | Sequential targeted Gemcitabine delivery |
Primary outcome
Extroducer® related Serious Adverse Events
Time frame: From each study treatment until 72 hours post treatment.
Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.
8 secondary outcomes
Gemcitabine related Serious Adverse Events
Time frame: From first study treatment on Day 0 until study completion, ~8 Months.
Overall Survival
Time frame: Through study completion, ~8 Months.
Progression Free Survival
Time frame: Through study completion, ~8 Months.
Tumor resectability
Time frame: Through study completion, ~8 Months.
Tumor response
Time frame: Through study completion, ~8 Months.
Tumor marker
Time frame: Through study completion, ~8 Months.
Patient Quality of Life
Time frame: Through study completion, ~8 Months.
Incidence of Adverse Events and Device Deficiencies
Time frame: Through study completion, ~8 Months.
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 12 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) are not planned to be shared. Study results will be reported in aggregate form through peer-reviewed publications.
Related trials for Pancreatic Cancer Non-resectable
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine and Extroducer Infusion Catheter System in people with Pancreatic Cancer Non-resectable, run by Smartwise Sweden AB at 1 site in Sweden.
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 16 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Contact Ulrik Birgersson, PhD, MSc (+46 70 842 10 54, Ulrik.Birgersson@smartcella.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extroducer® related Serious Adverse Events (time frame: From each study treatment until 72 hours post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.