Clinical trialPhase 1Recruiting
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 9 January 2024
- Expected end
- June 2028
- Enrollment
- 58 participants
- Sites
- 6
- Primary outcomes
- Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D); Dose-limiting toxicity (DLT); Adverse events (AE) and severe adverse events (SAE)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 10 June 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC or advanced pancreatic cancer with lymph node metastases remain unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6008 injection. The primary objective is to evaluate the safety of NRT6008 Injection. While the secondary objectives include the assessments of the preliminary efficacy. In addition, the distribution of NRT6008 injection in human body, and the changes of tumor biomarkers and the improvement of cancer pain status of participants after administration will also be evaluated.