Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Overview

About this study

The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 (m)FOLFIRINOX and SBRT.
  • Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy.
  • Female or male subjects ≥ 18 years of age.
  • ECOG performance status of 0-2.
  • Adequate end-organ function.

Exclusion Criteria:

  • Subjects with documented metastatic disease.
  • First-line chemotherapy other than (m)FOLFIRINOX and/or chemotherapy given for a total period of longer than 4 months prior to start of SBRT.
  • Prior abdominal RT with substantial overlap in radiation fields.
  • Subjects not recovered/controlled from treatment-related toxicities.
  • Uncontrolled malignancy other than PC 6. 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.

Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Merrell, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions