About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- NRT6008 Injection + Systematic chemotherapy