Effect of Intratumoral Injection of Gene Therapy for Locally Advanced Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

January 30, 2017

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Pancreatic Adenocarcinoma
Interventions
DRUG

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)."

DRUG

Gemcitabine

Gemcitabine alone 3 weeks/month during 6 months (or until progression).

Trial Locations (7)

13009

Institut Paoli Calmettes, Marseille

13015

CHU de Marseille Hôpital Nord, Marseille

31059

Rangueil Hospital, Toulouse

32110

APHP Hôpital Beaujon, Clichy

34298

Institut régional du Cancer, Montpellier

69008

Hôpital privé Jean Mermoz, Lyon

94800

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BIOTHERAPY department of the clinical center of investigation- CIC 1436, Toulouse

UNKNOWN

collaborator

InvivoGen Therapeutics

UNKNOWN

lead

University Hospital, Toulouse

OTHER

NCT02806687 - Effect of Intratumoral Injection of Gene Therapy for Locally Advanced Pancreatic Cancer | Biotech Hunter | Biotech Hunter