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

Launched by CHENGDU NEW RADIOMEDICINE TECHNOLOGY CO. LTD. · Feb 19, 2024

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ClinConnect Summary

This clinical trial is looking at a new treatment called NRT6008 for patients with unresectable locally advanced pancreatic cancer, which means the cancer cannot be removed through surgery. The study aims to see how safe and effective this treatment is. It is currently recruiting participants who are between 18 and 80 years old, have been diagnosed with pancreatic cancer, and have specific health conditions that make surgery not an option for them. To qualify, patients need to have at least one measurable tumor in their pancreas and be in good overall health, meaning their organs and blood counts should be functioning normally.

Participants in this trial can expect close monitoring for safety and effectiveness throughout the study, as both a safety review committee and an independent review committee will be overseeing the results. If you or a loved one is considering joining this trial, it’s important to know that there are specific criteria that must be met, including not having had previous treatments for pancreatic cancer and being free of certain other health issues. This study offers a potential new option for patients facing a challenging diagnosis, and it involves following strict guidelines to ensure the safety of all participants.

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Eligibility criteria

• 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.;
• • 11. 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;
• • 12. Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;
• • 13. Positive for human immunodeficiency virus (HIV) antibodies;
• • 14. 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);
• • 15. 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;
• • 16. Participants with syphilis infection or active tuberculosis;
• • 17. Other reasons deemed unsuitable for participation in this trial by the investigators.