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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChengdu New Radiomedicine Technology Co. LTD.

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

Treatment groups

58 Participants
are divided into 1 treatment group