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Unresectable Locally Advanced Pancreatic CarcinomaPhase 1NCT07555587

Safety and Efficacy of NRT6008 Administered in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Carcinoma (LAPC)

A Phase 1 study testing NRT6008 Injection and Systematic chemotherapy in people with Unresectable Locally Advanced Pancreatic Carcinoma, run by NRT MedTech Australia Pty Ltd at 1 site in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a phase Ib, open-label study to evaluate safety and efficacy of NRT6008 in combination with standard-of-care chemotherapy in patients with unresectable Locally Advanced Pancreatic Carcinoma (LAPC). Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
NRT6008 Injection and Systematic chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteAustralia
Study dates
Sep 2026to Jun 2029
Phase
Phase 1
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 and ≤85 years of age and able to understand and sign the informed consent form (ICF).
  • Histopathological or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas.
  • Deemed by the Investigator to have unresectable locally advanced pancreatic cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
  • Life expectancy of at least 3 months in the opinion of the Investigator.
  • Must have only one measurable target radiologically confirmed lesion in the pancreas according to RECIST 1.1, with the longest diameter of ≤ 6 cm and the shortest diameter of ≥ 2 cm (based on baseline imaging).
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  • Adequate organ and marrow function as defined by the following criteria:
  • Renal function: Blood creatinine ≤ 1.5 × the upper limit of normal (ULN), or eGFR ≥ 60 mL/min [by a clinically validated calculator such as Modification of diet in renal disease (MDRD) formula];
  • Liver function: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3×ULN; serum total bilirubin ≤ 1.5×ULN*
  • For study participants with recent biliary obstruction treated by drainage (e.g. stent), serum total bilirubin of > 1.5×ULN will be accepted for study entry provided that serial levels demonstrate clear improvement. In addition, chemotherapy should not be commenced until serum bilirubin is ≤ 1.5×ULN.
  • Bone marrow function (without transfusion or treatment with granulocyte-colony stimulating factor (G-CSF), human thrombopoietin (TPO), or TPO receptor agonists (TPO-RAs) within 14 days before signing the ICF: Neutrophil count ≥ 1.5×10^9/L, haemoglobin ≥ 90 g/L, platelets≥ 100×10^9/L;
  • Coagulation function: International normalised ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause.
  • WOCBP and male participants must agree to use a highly effective method of contraception after signing the ICF, during the study, and for 12 months after administration of NRT6008.
  • Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 12 months after the administration of NRT6008. All male participants must agree to not donate sperm during the study and for at least 12 months after NRT6008 administration.

Who cannot join

  • Allergic to the investigational device NRT6008 Injection or any of its components.
  • Participants who are deemed by the Investigator to be clinically inappropriate for treatment with either standard-of-care chemotherapy regimen (Regimen group A or Regimen group B).
  • Prior anti-tumour therapy for pancreatic carcinoma, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
  • Contraindications to anaesthesia.
  • Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer in the past 5 years. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the study Sponsor, if it is determined not to put the participant at an increased risk of adverse device effects and/or interfere with the integrity of study outcome.
  • Presence or suspicion of distant metastasis, including non-regional lymph nodes, on imaging.
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  • Pregnant or lactating women.
  • The participant is considered by the Investigator to be at an unacceptably high risk for the EUS-FNI procedure, or the procedure is deemed technically infeasible based on clinical judgment.
  • Radiation injury to the stomach, duodenum, or peritoneum, and/or other conditions that put the participant at an increased risk of intervention-related toxicities such as certain types of prior abdominal surgery that significantly alters the upper abdomen anatomy, by Investigator judgment.
  • Presence of uncontrolled or unstable chronic medical conditions despite appropriate treatment (e.g., hypertension, diabetes mellitus), or any medical condition that, in the Investigator's judgment, would compromise participant safety or study participation, or interfere with the integrity of study outcomes.
  • History of acute pancreatitis, severe gastrointestinal haemorrhage, a severe cardio- or cerebrovascular event (including but not limited to stroke, unstable angina pectoris) within 6 months before the first dose of chemotherapy regimen, or presence of an active infection requiring systemic treatment within 2 weeks prior to first dose of chemotherapy regimen.
  • Participation in any other clinical study within 1 month before the first dose of the chemotherapy regimen.
  • Positive status for human immunodeficiency virus (HIV).
  • For participants positive for HBsAg and/or HBcAb, hepatitis B virus (HBV) DNA must be undetectable or <500 IU/mL to be eligible. Antiviral therapy must be maintained throughout the study period, where clinically applicable.
  • Participants who are positive for hepatitis C virus (HCV) antibody must have undetectable HCV RNA to be eligible for enrolment.
  • Patients with syphilis infection or active tuberculosis.
  • Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptable high risk for toxicities or limit participant ability to complete study procedure(s).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nam Nguyen contact

0422113598

QUOCNAM.NGUYEN@SA.GOV.AU

Australia1 site

  • Royal Adelaide Hospital

    Adelaide

    Nam Nguyen, 0422113598, QUOCNAM.NGUYEN@SA.GOV.AU

Other trials in Australia

About this study

Official title: A Phase Ib Trial to Evaluate the Safety and Efficacy of NRT6008 Plus Chemotherapy in Unresectable Locally Advanced Pancreatic Carcinoma

This is a phase Ib, open-label study to evaluate safety and efficacy of NRT6008 in combination with standard-of-care chemotherapy in patients with unresectable Locally Advanced Pancreatic Carcinoma (LAPC).

Read the detailed description

The efficacy and safety of Yttrium-90 carbon microspheres in patientswith unresectable LAPC remain unknown. This trial is a prospective, multicenter,open-label, single-arm phase I trial designed to evaluate the safety and efficacyof NRT6008 injection.The primary objective is to evaluate the safety of NRT6008 Injection. While the secondary objectives include the assessments of the preliminary efficacy. In addition, the changes of tumor biomarkers and the improvement of cancer pain status of participants after administration will also be evaluated.

Being tested
NRT6008 Injection, Systematic chemotherapy
Keywords
Yttrium-90, Endoscopic ultrasound-guided fine-needle injection, Locally Advanced Pancreatic Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRT6008 InjectionDevice

    In this study, all participants shall receive NRT6008 injection (for 200 Gy tumour tissue absorbed dose).

  • Systematic chemotherapyDrug

    Participants will be assigned to receive chemotherapy (GN or (m)FOLFIRINOX) at the Investigator's discretion and in accordance with institutional practice. Chemotherapy will be initiated in Cycle 1. The investigational device, NRT6008 Injection, will be administered 10 days (±3 days) after completion of the tumour assessment in Cycle 1. Participants will then receive Cycle 2 Day 1 chemotherapy 7 days (±1 day) following NRT6008 administration. The Investigator-assigned chemotherapy regimen will continue throughout the study until the occurrence of disease progression, intolerance to chemotherapy, death, loss to follow-up, or determination of eligibility for surgical resection (including R0 or R1 resection), whichever occurs first.

Study groups in NCT07555587
Study groupRoleWhat they receive
NRT6008 InjectionExperimentalIn this study, participants shall receive NRT6008 injection in combination with chemotherapy.
Receives: Device: NRT6008 Injection; Drug: Systematic chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AE) and severe adverse events (SAE)

    Properties, incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) per Common Terminology Criteria for Adverse Events (CTCAE) v6.0, abnormal laboratory parameters, vital signs, physical examinations, and electrocardiogram (ECG) results

    Measured: Through study completion, an average of 18 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1

    Measured: Through study completion, an average of 18 months

  2. Duration of response (DOR)

    According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1

    Measured: Through study completion, an average of 18 months

  3. Progression-free survival (PFS)

    According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1

    Measured: Through study completion, an average of 18 months

  4. Overall survival (OS)

    How long the participant lives after the trial intervention

    Measured: Through study completion, an average of 18 months

  5. Surgical resection rate (R0+R1 resection)

    R0 (≥1 mm margin), R1 (<1 mm clearance)

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555587
Sponsor's protocol ID
NRTPacAU-1
Status last verified
Apr 2026
First submitted
16 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NRT6008 Injection and Systematic chemotherapy in people with Unresectable Locally Advanced Pancreatic Carcinoma, run by NRT MedTech Australia Pty Ltd at 1 site in Australia.

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 15 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: opening soon, as of the sponsor's last update on 29 Apr 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 Australia. 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 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.

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 Nam Nguyen (0422113598, QUOCNAM.NGUYEN@SA.GOV.AU), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AE) and severe adverse events (SAE) (time frame: Through study completion, an average of 18 months). 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 NCT07555587.

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 29 Apr 2026.

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