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Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC

RecruitingNAAges 18 Years - anyAllBetaGlue Therapeutics SpA
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically. It will also learn about the safety of the new treatment when combined with chemotherapy. The treatment involves injecting a radioactive implant (medical device) directly into the pancreatic tumour on one occasion only. The main questions it aims to answer are: * Is the new treatment safe and tolerable when used in combination with standard of care chemotherapy. * Is it feasible to inject the new treatment directly into a patient's pancreatic tumour. * What is the impact of this new treatment on a patient's quality of life including a pain evaluation. * To assess how the pancreatic tumour responds to the treatment during the 3 month follow up. Participants will: * Participate in the research study for approximately 7 months and will rece

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📋 Eligibility rules (as published)
Inclusion Criteria (Main): * Histologically or cytologically proven Pancreatic Adenocarcinoma. * Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer. * No prior radiotherapy for pancreatic cancer. * Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice. * Life expectancy of ≥6 months at screening. Exclusion Criteria (Main): * Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET assessment. * Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy. * More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or decision made by the local MDTB. * ECOG is higher than 1. * History of malignancy in the last 3 years. * Blood clotting disorders (INR \> 1.5, PLT \< 50,000/µl - risk of bleeding during organ puncture). * Active systemic or local infection (e.g. peritonitis, abscess). * Severe organ failure (e.g. end-stage liver, kidney, heart failure). * Cardiological and other diseases that threaten the use of anesthesia. * Pancreatitis (acute or exacerbation of chronic inflammation).
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What it tests

  • Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas
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Where

2 sites
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Roma, Italy
Guy's & St Thomas' and Kings College Hospitals
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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