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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
-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.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGSecond Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGShanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)
Optimal dose for NRT6008 injection
Time frame: 28 days after NRT6008 administration
Dose-limiting toxicity (DLT)
Incidence rate of DLT
Time frame: 28 days after NRT6008 administration
Adverse events (AE) and severe adverse events (SAE)
Incidence rate and severity of AE and SAE
Time frame: Up to 52 weeks
Objective response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)
Time frame: Up to 52 weeks
Duration of response (DOR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)
Time frame: Up to 52 weeks
Progression-free survival (PFS)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)
Time frame: Up to 52 weeks
Overall survival (OS)
How long the participant lives after the administration
Time frame: Up to 52 weeks
Resection rate (R0 and R1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, China
RECRUITINGR0 (≥1 mm margin), R1 (\<1 mm clearance)
Time frame: Up to 52 weeks