This is a phase Ib, open-label study to evaluate safety and efficacy of NRT6008 in combination with standard-of-care chemotherapy in patients with unresectable Locally Advanced Pancreatic Carcinoma (LAPC).
The efficacy and safety of Yttrium-90 carbon microspheres in patientswith unresectable LAPC remain unknown. This trial is a prospective, multicenter,open-label, single-arm phase I trial designed to evaluate the safety and efficacyof 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 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
10
In this study, all participants shall receive NRT6008 injection (for 200 Gy tumour tissue absorbed dose).
Participants will be assigned to receive chemotherapy (GN or (m)FOLFIRINOX) at the Investigator's discretion and in accordance with institutional practice. Chemotherapy will be initiated in Cycle 1. The investigational device, NRT6008 Injection, will be administered 10 days (±3 days) after completion of the tumour assessment in Cycle 1. Participants will then receive Cycle 2 Day 1 chemotherapy 7 days (±1 day) following NRT6008 administration. The Investigator-assigned chemotherapy regimen will continue throughout the study until the occurrence of disease progression, intolerance to chemotherapy, death, loss to follow-up, or determination of eligibility for surgical resection (including R0 or R1 resection), whichever occurs first.
Royal Adelaide Hospital
Adelaide, Australia
Adverse events (AE) and severe adverse events (SAE)
Properties, incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) per Common Terminology Criteria for Adverse Events (CTCAE) v6.0, abnormal laboratory parameters, vital signs, physical examinations, and electrocardiogram (ECG) results
Time frame: Through study completion, an average of 18 months
Objective response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1
Time frame: Through study completion, an average of 18 months
Duration of response (DOR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1
Time frame: Through study completion, an average of 18 months
Progression-free survival (PFS)
According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1
Time frame: Through study completion, an average of 18 months
Overall survival (OS)
How long the participant lives after the trial intervention
Time frame: Through study completion, an average of 18 months
Surgical resection rate (R0+R1 resection)
R0 (≥1 mm margin), R1 (\<1 mm clearance)
Time frame: Through study completion, an average of 18 months
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