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
|