Titre A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer
Protocole ID GRECO-2
ClinicalTrials.gov ID NCT04698915
Type(s) de cancer Pancréas
Phase Phase II
Type étude Clinique
Médicament GC4711 en association avec la radiothérapie stéréotaxique corporelle
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville Montréal
Investigateur(trice) principal(e) Dr Tamim Niazi
Coordonnateur(trice) Rokaya Elmisri
 514-340-8222 poste 26510
Statut Actif en recrutement
Critètes d'éligibilité
  • Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
  • Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
  • Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
  • Remain non-metastatic as confirmed by a CT scan at screening.
  • Female or male subjects ≥ 18 years of age
  • ECOG performance status of 0-2
  • Adequate end-organ function
Critètes d'exclusion
  • Subjects with documented metastatic disease
  • First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
  • Prior abdominal RT with substantial overlap in radiation fields
  • Subjects not recovered/controlled from treatment-related toxicities
  • Uncontrolled malignancy other than PC
  • Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
  • Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy