Unresectable Pancreatic CancerPhase 1NCT06278454
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
A Phase 1 study testing NRT6008 Injection + Systematic chemotherapy in people with Unresectable Pancreatic Cancer and Advanced Pancreatic Cancer, run by Chengdu New Radiomedicine Technology Co. LTD. at 6 sites in China.
Trial summary
This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unresectable Pancreatic Cancer, Advanced Pancreatic Cancer, Lymph Node Metastases
- What is being tested?
- NRT6008 Injection + Systematic chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 6 sitesChina
- Study dates
- 9 Jan 2024to Jun 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
- Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
- Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having contraindications to surgery, or refusing surgical resection;
- ECOG performance status score ≤1;
- Expected survival ≥3 months;
- According to RECIST v1.1 criteria, there is only one measurable lesion in the pancreas confirmed by imaging, and the lesion has the shortest axis diameter ≥2.0 cm, the longest axis diameter ≤6.0 cm (based on baseline imaging);
- Adequate normal organ and marrow function as defined below: (1) Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min (calculated by the Cockcroft-Gault formula); (2) Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN; serum total bilirubin ≤1.5×ULN; (3) Bone marrow function [[no blood transfusion or granulocyte colony-stimulating factor (G-CSF), human thrombopoietin (TPO), or TPO receptor agonist treatment within 14 days prior to signing informed consent]: neutrophils ≥1.5×10^9/L, hemoglobin ≥90 g/L, platelets ≥100×10^9/L; (4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Female and male participants of reproductive age must voluntarily agree to practice strict and effective contraception after signing the informed consent form, during the study period, and within 12 months after administration of the investigational drug. Males are prohibited from donating sperm during this period. Female participants of reproductive age must have a negative pregnancy test result during the screening period and within 24 hours before administration of the investigational drug.
Who cannot join
- Allergic to the investigational drug NRT6008 injection itself or any of its components;
- Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
- Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;
- Contraindications to anesthesia;
- History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid cancer;
- Presence or suspected presence of distant metastases according to imaging;
Show all 17Show fewer
- Pregnant or lactating females;
- Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
- Evidence of radiographic invasion into stomach, duodenum or peritoneum;
- Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
- Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable angina), or occurrence of acute infections requiring systemic treatment within 2 weeks before the screening period;
- Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;
- Positive for human immunodeficiency virus (HIV) antibodies;
- Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or < 500 IU/mL will be eligible for inclusion in this study (use of antiviral drugs during the study period is required);
- Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;
- Participants with syphilis infection or active tuberculosis;
- Other reasons deemed unsuitable for participation in this trial by the investigators.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing
Weiqing Chen
Weiqing Chen
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
Zhaoshen Li
Yiqi Du
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality
Qi Li
Xueying Ding
- Recruiting
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Duanmin Hu
Duanmin Hu
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Bangmao Wang
Bangmao Wang
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Suxia Luo
Suxia Luo
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.
Read the detailed description
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC or advanced pancreatic cancer with lymph node metastases remain unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of 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 distribution of NRT6008 injection in human body, and 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, Advanced Pancreatic Cancer with Lymph Node Metastases
- Medical subject headings
- Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRT6008 Injection + Systematic chemotherapyDrug
Also called Investigational Product + Systematic chemotherapy
-Systematic chemotherapy The chemotherapy regimen is selected by the investigators at the consideration of participants' conditions, with either GN or (m)FOLFIRINOX.
GN: gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, every 21 days (3 weeks/cycle).
FOLFIRINOX: oxaliplatin 85 mg/m^2, irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 and fluorouracil 400 mg/m^2 given as a bolus followed by 2400 mg/m^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle).
mFOLFIRINOX: oxaliplatin 85 mg/m^2, irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, and fluorouracil 2400 mg/m^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle).
-NRT6008 injection administration: NRT6008 injection is implanted into pancreatic tumor via endoscopic ultrasound (EUS)-guided fine-needle injection, at the instruction of the investigator. The dose of NRT6008 injection is determined by tumor volume and selected tumor average absorbed dose.
| Study group | Role | What they receive |
|---|---|---|
| NRT6008 Injection | Experimental | In this study, participants shall receive NRT6008 injection in combination with chemotherapy. Receives: Drug: NRT6008 Injection + Systematic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)
Optimal dose for NRT6008 injection
Measured: 28 days after NRT6008 administration
Dose-limiting toxicity (DLT)
Incidence rate of DLT
Measured: 28 days after NRT6008 administration
Adverse events (AE) and severe adverse events (SAE)
Incidence rate and severity of AE and SAE
Measured: Up to 52 weeks
Secondary outcomes (5)
Objective response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)
Measured: Up to 52 weeks
Duration of response (DOR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)
Measured: Up to 52 weeks
Progression-free survival (PFS)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)
Measured: Up to 52 weeks
Overall survival (OS)
How long the participant lives after the administration
Measured: Up to 52 weeks
Resection rate (R0 and R1)
R0 (≥1 mm margin), R1 (<1 mm clearance)
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start9 Jan 2024
- 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 Unresectable Pancreatic CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu New Radiomedicine Technology Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278454
- Sponsor's protocol ID
- NrtPac-1
- Other IDs
- CTR20240312
- Status last verified
- Nov 2025
- First submitted
- 19 Feb 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
- ClinicalTrials.gov ID
- NCT06278454
- Acronym / sponsor ID
- NrtPac-1
- Keywords
- Yttrium-90, Endoscopic ultrasound-guided fine-needle injection, Locally Advanced Pancreatic Carcinoma, Advanced Pancreatic Cancer with Lymph Node Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chengdu New Radiomedicine Technology Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Feb 2024 (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 is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.
Detailed description
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC or advanced pancreatic cancer with lymph node metastases remain unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of 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 distribution of NRT6008 injection in human body, and the changes of tumor biomarkers and the improvement of cancer pain status of participants after administration will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRT6008 Injection | Experimental | Drug: NRT6008 Injection + Systematic chemotherapyIn this study, participants shall receive NRT6008 injection in combination with chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
- Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
- Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having contraindications to surgery, or refusing surgical resection;
- ECOG performance status score ≤1;
- Expected survival ≥3 months;
Key exclusion criteria (17 listed)
- Allergic to the investigational drug NRT6008 injection itself or any of its components;
- Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
- Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;
- Contraindications to anesthesia;
- History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid 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 |
|---|---|---|
| NRT6008 Injection + Systematic chemotherapyAlso: Investigational Product + Systematic chemotherapy-Systematic chemotherapy The chemotherapy regimen is selected by the investigators at the consideration of participants' conditions, with either GN or (m)FOLFIRINOX. GN: gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, every 21 days (3 weeks/cycle). FOLFIRINOX: oxaliplatin 85 mg/m^2, irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 and fluorouracil 400 mg/m^2 given as a bolus followed by 2400 mg/m^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle). mFOLFIRINOX: oxaliplatin 85 mg/m^2, irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, and fluorouracil 2400 mg/m^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle). -NRT6008 injection administration: NRT6008 injection is implanted into pancreatic tumor via endoscopic ultrasound (EUS)-guided fine-needle injection, at the instruction of the investigator. The dose of NRT6008 injection is determined by tumor volume and selected tumor average absorbed dose. | Drug | NRT6008 Injection |
Primary outcome
Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)
Time frame: 28 days after NRT6008 administration
Optimal dose for NRT6008 injection
Dose-limiting toxicity (DLT)
Time frame: 28 days after NRT6008 administration
Incidence rate of DLT
Adverse events (AE) and severe adverse events (SAE)
Time frame: Up to 52 weeks
Incidence rate and severity of AE and SAE
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 52 weeks
Duration of response (DOR)
Time frame: Up to 52 weeks
Progression-free survival (PFS)
Time frame: Up to 52 weeks
Overall survival (OS)
Time frame: Up to 52 weeks
Resection rate (R0 and R1)
Time frame: Up to 52 weeks
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 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Unresectable Pancreatic Cancer
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.
Zhaoshen Li principal investigator
Changhai Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NRT6008 Injection + Systematic chemotherapy in people with Unresectable Pancreatic Cancer and Advanced Pancreatic Cancer, run by Chengdu New Radiomedicine Technology Co. LTD. at 6 sites in China.
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 8 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: looking for participants now, as of the sponsor's last update on 10 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 6 sites in China. 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 Zhaoshen Li, MD (+8602131162338, zhsl@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D) (time frame: 28 days after NRT6008 administration). The study lists 3 primary outcomes in all. 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 10 Jun 2026.