NCT06278454

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

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Chengdu New Radiomedicine Technology Co. LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC 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.

Conditions

• Unresectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	NRT6008 Injection + Systematic chemotherapy	-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.

Timeline

• Start date: 2024-01-09
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2024-02-26
• Last updated: 2025-03-24

Locations

6 sites across 1 country: China