68
Participants
Start Date
January 30, 2017
Primary Completion Date
June 30, 2022
Study Completion Date
June 30, 2022
Gene Therapy product CYL-02
"Gene Therapy product CYL 02 = = plasmid DNA encoding SST2 + DCK::UMK genes pre-complexed to linear polyethylenimine.~Intratumoral injection of the gene therapy product CYL-02 (2,5 ml within the primary tumor under endoscopic ultrasound guidance an under propofol anaesthesia). The intratumoral injection of CYL-02 is followed by three IV infusions of Gemcitabine (1000 mg/m2) at 48 hours and then every week. A second Intratumoral injection of the gene therapy product CYL-02 is performed at a same dosage and volume, 30 days after the first administration followed by three infusions of gemcitabine (1000 mg/m2) according the same rhythm (48 hours and every week) and dose. Patients have infusion of Gemcitabine 3 weeks/month during 6 months (or until progression)."
Gemcitabine
Gemcitabine alone 3 weeks/month during 6 months (or until progression).
Institut Paoli Calmettes, Marseille
CHU de Marseille Hôpital Nord, Marseille
Rangueil Hospital, Toulouse
APHP Hôpital Beaujon, Clichy
Institut régional du Cancer, Montpellier
Hôpital privé Jean Mermoz, Lyon
Institut Gustave Roussy, Villejuif
Collaborators (1)
BIOTHERAPY department of the clinical center of investigation- CIC 1436, Toulouse
UNKNOWN
InvivoGen Therapeutics
UNKNOWN
University Hospital, Toulouse
OTHER