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Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC)

NCT06278454•Chengdu New Radiomedicine Technology Co. LTD.

View on ClinicalTrials.gov

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. 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 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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
•2. Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
•3. Evaluated as unresectable LAPC by the investigator, or having contraindications to surgery, or refusing surgical resection (only patients with non-regional lymph node metastasis are eligible);
•4. ECOG performance status score ≤1;
•5. Expected survival ≥3 months;
•6. 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);
•7. 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;
•8. 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.

Exclusion Criteria

•1. Allergic to the investigational drug NRT6008 injection itself or any of its components;
•2. Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
•3. 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;
•4. Contraindications to anesthesia;
•5. 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;
•6. Presence or suspected presence of distant metastases according to imaging;
•7. Pregnant or lactating females;
•8. Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
•9. Evidence of radiographic invasion into stomach, duodenum or peritoneum;
•10. Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
+7 more criteria

Locations (6)

Henan Cancer Hospital

Zhengzhou, Henan, China

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Chongqing University Cancer Hospital

Chongqing, China

Tianjin Medical University General Hospital

Tianjin, China

Key Dates

Start Date

January 9, 2024

Primary Completion Date

December 1, 2027

Completion Date

June 1, 2028

Last Updated

March 24, 2025

Enrollment

ESTIMATED participants

Conditions

Unresectable Pancreatic Cancer

Interventions

NRT6008 Injection + Systematic chemotherapy

DRUG

Contacts

Zhaoshen Li, MD

CONTACT

+8602131162338 zhsl@vip.163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)

Inclusion Criteria

Exclusion Criteria

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