RecruitingPhase 1NCT06278454

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)

Sponsor

Chengdu New Radiomedicine Technology Co. LTD.

Enrollment

58 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Unresectable Pancreatic Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new treatment called NRT6008 can safely and effectively treat locally advanced pancreatic cancer that cannot be surgically removed. Pancreatic cancer is difficult to treat, and new options are urgently needed. **You may be eligible if...** - You are between 18 and 80 years old - You have pancreatic adenocarcinoma confirmed by biopsy or lab test - Your cancer has been assessed as unresectable (cannot be surgically removed) or you have refused or have contraindications to surgery - You have one measurable tumor in the pancreas of a specific size range - Your general health is good (ECOG 0-1) with expected survival over 3 months - Your kidney, liver, bone marrow, and clotting function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body beyond regional lymph nodes - Your organ function does not meet the required thresholds - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNRT6008 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.