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
      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