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.
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;
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;
Single group
NRT6008 Injection + Systematic chemotherapy
Drug-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.
Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)
Optimal dose for NRT6008 injection
Dose-limiting toxicity (DLT)
Incidence rate of DLT
Adverse events (AE) and severe adverse events (SAE)
Incidence rate and severity of AE and SAE
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)
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)
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)
Overall survival (OS)
How long the participant lives after the administration
Concentration of tumor biomarkers
Changes of tumor biomarkers through the study
Numeric rating scale (NRS) of pain
Changes of Numeric rating scale (NRS) score. Patients should choose from 4 main categories, totaling 11 scores (0-10): namely no pain (0), mild pain (1-3), moderate pain (4-6), severe pain (7-10). As the score increases, the intensity of pain also rises.
Distribution of NRT6008 injection in human body and radioactivity of biological samples
Distribution of NRT6008 injection in human body and radioactivity of Yttrium-90 in blood, urine, and feces (if available)
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