Status:
NOT_YET_RECRUITING
Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC
Lead Sponsor:
BetaGlue Therapeutics SpA
Conditions:
Pancreatic Ductal Adenocarcinoma (PDAC)
Locally Advanced
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 tre...
Detailed Description
The study is a multicentre, open-label, prospective, early feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose™ treatment following percutaneous administ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07155850
Start Date
January 1 2026
End Date
February 1 2027
Last Update
September 4 2025
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