YntraDose™ given before chemotherapy for locally advanced, unresectable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label early feasibility investigation enrolls patients with unresectable locally advanced pancreatic ductal adenocarcinoma to receive a single percutaneous, image-guided intratumoral injection of YntraDose™ followed by standard chemotherapy (FOLFIRINOX or gemcitabine/nab‑paclitaxel). YntraDose™ delivers Y-90 microspheres in a glue matrix to localize beta radiation within the tumor and is designed for single-use intratumoral administration under ultrasound/CT guidance. Primary objectives are safety, tolerability and feasibility of percutaneous delivery, with secondary assessments of tumor response, pain, quality of life, and potential conversion to resectability during roughly seven months of participation including a three-month follow-up. Patients will continue standard of care chemotherapy throughout participation and will be monitored with imaging and clinical assessments.

Why it matters

Who can join: the full rules

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).

Where it's running

• Fondazione Policlinico Universitario A. Gemelli, IRCCS
  Roma, Italy Recruiting
• Guy's & St Thomas' and Kings College Hospitals
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Carol Hegarty, PhD
• Email: c.hegarty@betaglue.com
• Phone: +44 7752 303229

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating REC-1245 for advanced or metastatic cancer

  This study is testing a new oral medication called REC-1245 to see if it can help people with advanced or metastatic cancer who haven't responded well to standard treatments.

  Recruiting at 6 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Duarte, California and 6 other locations · NCT06678659

• Accelerated immuno chemoradiotherapy for advanced lung cancer

  This study is testing a new fast treatment combining radiation and chemotherapy for people with advanced lung cancer to see if it works better than the usual approach.

  Recruiting at 10 sites Phase 2 TheraOp · Dresden and 10 other locations · NCT06102057

• KRAS Inhibitor ETX-929 in advanced solid tumors

  This trial tests ETX-929, alone or with cetuximab, in people whose cancers have KRAS mutations and have progressed after prior therapy.

  Recruiting Phase 1/2 Ensem Therapeutics · Fairfax, Virginia · NCT07912593

• Modified FOLFIRINOX with Pentamidine in Advanced Pancreatic Cancer

  This study tests whether adding pentamidine to a modified FOLFIRINOX regimen helps people with advanced or metastatic pancreatic cancer.

  Recruiting Phase 1 University of Oklahoma · Oklahoma City, Oklahoma · NCT07829185

• Targeted alpha-radiation therapy for NTSR1-positive tumors using SKL35501/SKL35502

  This early-phase trial tests whether a two-part approach—an imaging agent to find NTSR1-expressing tumors and a targeted alpha-ray therapy—can be safely used in adults with certain advanced solid tumors.

  Recruiting Phase 1 SK Life Science, Inc. · Glen Burnie, Maryland and 4 other locations · NCT07812805

• Zoldonrasib plus Daraxonrasib vs Gemcitabine and Nab-Paclitaxel as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This study tests whether two investigational RAS inhibitors together can improve outcomes compared with standard chemotherapy in adults with newly diagnosed metastatic pancreatic cancer carrying the KRAS G12D mutation.

  Recruiting at 6 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 5 other locations · NCT07805954

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.