Clinical trial · Interventional
Gene Therapy of Pancreatic Ductal Adenocarcinoma
PILOT STUDY OF GENE THERAPY FOR LOCALLY ADVANCED PANCREATIC ADENOCARCINOMA WITH INTRATUMOURAL INJECTION OF JetPEI/DNA COMPLEXES WITH ANTITUMOURAL EFFECT AND CHEMOSENSITIZING ACTIVITY FOR GEMCITABINE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is given as a palliative therapy. Aim of the present study is to evaluate the feasibility, tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with unresectable pancreatic carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapy
- interventionNames
- Genetic: Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes
Primary outcomes (1)
- measure
- Feasability and security : Number of Participants with Adverse Events
- timeFrame
- 60 days
- description
- Feasibility, security (pancreas and general) of intratumor injections of the gene therapy product (CYL-02 plasmid DNA pre-complexed to PEI encoding sst2 dck::umk) administered under endoscopic ultrasound guidance and followed by gemcitabine treatment at standard doses.
Secondary outcomes (1)
- measure
- Antitumoral effect: secondary resecability, transgenes diffusion
- timeFrame
- 60 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with a pancreatic adenocarcinoma histologically proven and/or a solid pancreatic mass associated with on or multiple metastatis from pancreatic origin (histologically proven) * Patient with a non resectable pancreatic adenocarcinoma (on preoperative CT-scan and/or endoscopic ultrasound evaluation) * Pancreatic tumor that could be evaluated by endoscopic ultrasound (no digestive stenosis, no gastrectomy) * Patient with no contraindication to général anaesthesia. * Karnofsky index \>= 70% * Written informed consent given Exclusion Criteria: * \- Exclusion period for another clinical trial or research protocol. * Patient unable to read or understand information/consent formula or unable to decide alone for his participation to the trial * Patient under tutelage * Pregnant woman or able to procreate without contraception. * Patient with pancreatic cystic tumor or pancreatic pseudocyst. * Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastasis). * Patient contraindication to Gemzar® : * Hypersensitivity to Gemcitabine. * Decision of radiotherapy * Granulocytes \< 1000/mm3 * Thrombocytes \< 100 000/mm3 * Patient not efficiently treated for jaundice (biliary stent or bypass) if present at time of diagnosis * Contraindication for fine needle aspiration biopsy under endoscopic ultrasound (hemostasis trouble).
References
Publications (0)
Data not yet available