Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)
- Conditions
- Unresectable Pancreatic Cancer
- Registration Number
- NCT06278454
- Lead Sponsor
- Chengdu New Radiomedicine Technology Co. LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria:<br><br> 1. Aged =18 years, able to comprehend and sign an informed consent form;<br><br> 2. Diagnosed with pancreatic ductal adenocarcinoma confirmed histologically or<br> cytologically;<br><br> 3. Evaluated as unresectable LAPC by the investigator, or having contraindications to<br> surgery, or refusing surgical resection;<br><br> 4. ECOG performance status score =1;<br><br> 5. Expected survival =3 months;<br><br> 6. According to RECIST v1.1 criteria, there is only one measurable lesion in the<br> pancreas confirmed by imaging, and the lesion has the shortest axis diameter =2.0<br> cm, the longest axis diameter =6.0 cm (based on baseline imaging);<br><br> 7. Adequate normal organ and marrow function as defined below: (1) Renal function:<br> serum creatinine =1.5×ULN, or creatinine clearance =60 mL/min (calculated by the<br> Cockcroft-Gault formula); (2) Liver function: aspartate aminotransferase (AST) or<br> alanine aminotransferase (ALT) =3×ULN; serum total bilirubin =1.5×ULN; (3) Bone<br> marrow function [[no blood transfusion or granulocyte colony-stimulating factor<br> (G-CSF), human thrombopoietin (TPO), or TPO receptor agonist treatment within 14<br> days prior to signing informed consent]: neutrophils =1.5×10^9/L, hemoglobin =100<br> g/L, platelets =80×10^9/L; (4) Coagulation function: International normalized ratio<br> (INR) or prothrombin time (PT) =1.5×ULN, and activated partial thromboplastin time<br> (APTT) =1.5×ULN;<br><br> 8. Female and male participants of reproductive age must voluntarily agree to practice<br> strict and effective contraception after signing the informed consent form, during<br> the study period, and within 12 months after administration of the investigational<br> drug. Males are prohibited from donating sperm during this period. Female<br> participants of reproductive age must have a negative pregnancy test result during<br> the screening period and within 24 hours before administration of the<br> investigational drug.<br><br>Exclusion Criteria:<br><br> 1. Allergic to the investigational drug NRT6008 injection itself or any of its<br> components;<br><br> 2. Contraindications to any of the three optional systemic chemotherapy regimens in<br> this study judged by investigators;<br><br> 3. Previous anti-tumor treatments for pancreatic cancer, including but not limited to<br> chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for<br> discontinuation of traditional chinese medicine or herbal medicine for at least 7<br> days prior to the screening period;<br><br> 4. Contraindications to anesthesia;<br><br> 5. History of any other malignant tumors within 5 years before receiving<br> investigational drug treatment, except for cases of cured non-melanoma skin cancer,<br> cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1<br> endometrial carcinoma, or thyroid cancer;<br><br> 6. Presence or suspected presence of distant metastases according to imaging;<br><br> 7. Pregnant or lactating females;<br><br> 8. Participants assessed by the investigators to be at high risk or had difficulty in<br> operation for EUS-FNI procedures;<br><br> 9. Evidence of radiographic invasion into stomach,duodenum or peritoneum;<br><br> 10. Participants with chronic diseases that are actively treated but not well<br> controlled, such as primary hypertension (e.g. >150/100 mmHg), diabetes (meeting<br> diagnostic criteria for diabetes, e.g. fasting blood glucose =7.0 mmol/L, and/or<br> postprandial blood glucose =11.1 mmol/L), etc.;<br><br> 11. Within 6 months prior to the screening period, occurrence of acute or chronic<br> pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases<br> (including but not limited to stroke, unstable angina), or occurrence of acute<br> infections requiring systemic treatment within 2 weeks before the screening period;<br><br> 12. Participated in other interventional clinical trials within 30 days prior to<br> screening period;<br><br> 13. Positive for human immunodeficiency virus (HIV) antibodies;<br><br> 14. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or hepatitis B core<br> antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below<br> the lower limit of the reference range or < 500 IU/mL will be eligible for inclusion<br> in this study (use of antiviral drugs during the study period is required);<br><br> 15. Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required,<br> participants with negative HCV RNA results will be eligible for inclusion in this<br> study;<br><br> 16. Participants with syphilis infection or active tuberculosis;<br><br> 17. Other reasons deemed unsuitable for participation in this trial by the<br> investigators.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) or the recommended phase ? dose (RP2D);Dose-limiting toxicity (DLT);Adverse events (AE) and severe adverse events (SAE)
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR);Duration of response (DOR);Progression-free survival (PFS);Overall survival (OS);Resection rate (R0 and R1)