GRECO-2: GC4711 + SBRT for pancreatic cancer
What is the Purpose of this Study?
The study has three parts: a screening period, a study dosing period, and a follow-up period.
If you choose to join the study, you will:
- Go through a screening period that includes a review of your medical record, test results, and one clinic visit
- Have radiation therapy called stereotactic body radiation therapy (SBRT) and chemotherapy, which are standard of care for your disease
During the dosing period of this study, you will:
- Be randomized (like flipping a coin) to one of two groups:
-- Group 1: Get the study drug (GC4711) in your vein and radiation for 5 days
-- Group 2: Get a placebo (harmless sugar water) in your vein and radiation for 5 days
During the follow-up time you will:
- Have regular study visits for 5 years.
- Have a physical exam, vital signs assessed, be asked about your side effects and any medications you are taking at each visit.
- Have blood samples taken, a CT and/or MRI scan, an electrocardiogram (ECG) and complete surveys questionnaires about how you are feeling
If you choose to join the study, you will:
- Go through a screening period that includes a review of your medical record, test results, and one clinic visit
- Have radiation therapy called stereotactic body radiation therapy (SBRT) and chemotherapy, which are standard of care for your disease
During the dosing period of this study, you will:
- Be randomized (like flipping a coin) to one of two groups:
-- Group 1: Get the study drug (GC4711) in your vein and radiation for 5 days
-- Group 2: Get a placebo (harmless sugar water) in your vein and radiation for 5 days
During the follow-up time you will:
- Have regular study visits for 5 years.
- Have a physical exam, vital signs assessed, be asked about your side effects and any medications you are taking at each visit.
- Have blood samples taken, a CT and/or MRI scan, an electrocardiogram (ECG) and complete surveys questionnaires about how you are feeling
What is the Condition Being Studied?
People with localized pancreatic cancer
Who Can Participate in this Study?
Adults ages 18+ who:
- Have pancreatic cancer that has not spread (nonmetastatic) but cannot be treated with surgery
- Plan to have chemotherapy and radiation treatment for your cancer
- Have normal organ function
- Have not had radiation to the same area before
- Agree to use contraception (birth control) while in the study if you are able to have children
For more information about who can be in this study, please contact the study team.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out how the experimental drug (GC4711) works in your body and against your cancer when combined with radiation therapy.
Study Details
Full Title
GRECO-2: A Randomized, Phase 2b Study of Stereotactic Body Radiation Therapy (SBRT) in combination with GC4711 in the Treatment of Unresectable or Borderline Resectable, Nonmetastatic Pancreatic Cancer
Principal Investigator
Protocol Number
IRB:
PRO00107456
NCT:
NCT04698915
ClinicalTrials.gov
View on ClinicalTrials.gov