---
title: Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
nct_id: NCT04698915
overall_status: TERMINATED
phase: PHASE2
sponsor: Galera Therapeutics, Inc.
study_type: INTERVENTIONAL
primary_condition: SBRT
countries: United States, Canada, France, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04698915.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04698915"
ct_last_update_post_date: 2024-05-21
last_seen_at: "2026-05-12T07:34:39.092Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

**Official Title:** GRECO-2: 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

**NCT ID:** [NCT04698915](https://clinicaltrials.gov/study/NCT04698915)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Futility Analysis
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 177
- **Lead Sponsor:** Galera Therapeutics, Inc.
- **Conditions:** SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer
- **Start Date:** 2021-05-07
- **Completion Date:** 2023-11-30
- **CT.gov Last Update:** 2024-05-21

## Brief Summary

GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
2. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
3. Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
4. Remain non-metastatic as confirmed by a CT scan at screening.
5. Female or male subjects ≥ 18 years of age
6. ECOG performance status of 0-2
7. Adequate end-organ function

Exclusion Criteria:

1. Subjects with documented metastatic disease
2. First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
3. Prior abdominal RT with substantial overlap in radiation fields
4. Subjects not recovered/controlled from treatment-related toxicities
5. Uncontrolled malignancy other than PC
6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
7. Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
```

## Arms

- **Arm A Active GC4711** (EXPERIMENTAL)
- **Arm B Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Drug GC4711** (DRUG) — 15 Minute IV Infusion
- **Placebo** (DRUG) — 15 Minute IV Infusion

## Primary Outcomes

- **Overall Survival** _(time frame: From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months))_ — Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.

## Locations (35)

- Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
- Cedars-Sinai Medical Center, Los Angeles, California, United States
- University of Miami, Miami, Florida, United States
- Orlando Health Cancer Institute, Orlando, Florida, United States
- Moffitt Cancer Center, Tampa, Florida, United States
- University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
- University of Kansas Medical Center, Kansas City, Kansas, United States
- Henry Ford Hospital, Detroit, Michigan, United States
- Mayo Clinic Rochester, Rochester, Minnesota, United States
- Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
- Hackensack Meridian Health, Hackensack, New Jersey, United States
- Northwell Health, Lake Success, New York, United States
- Icahn School of Medicine at Mount Sinai, New York, New York, United States
- Duke University Medical Center, Durham, North Carolina, United States
- University Hospitals of Cleveland, Cleveland, Ohio, United States
- Radiation Oncology and Gamma Knife Center of Oregon, Portland, Oregon, United States
- Pennsylvania State University, University Park, Pennsylvania, United States
- UT Southwestern Medical, Dallas, Texas, United States
- MD Anderson Cancer Center, Houston, Texas, United States
- University of Washington Medical Center (UWMC) - Radiation Oncology Center, Seattle, Washington, United States
- Cancer Care Northwest, Spokane Valley, Washington, United States
- London Regional Cancer Center, London, Ontario, Canada
- Jewish General Hospital, Montreal, Quebec, Canada
- Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
- Institut Bergonié, Bordeaux, France
- CHRU de Brest Hôpital Morvan, Brest, France
- Centre Georges François Leclerc, Dijon, France
- Institut régional du Cancer de Montpellier, Montpellier, France
- Tenon Hospital, Paris, France
- CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France
- Aberdeen Royal Infirmary, Aberdeen, Aberdeenshire, United Kingdom
- GenesisCare, Oxford, Oxfordshire, United Kingdom
- Addenbrookes Hospital, Cambridge, United Kingdom
- Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
- Imperial College London, Saint Mary's Hospital, London, United Kingdom

## Recent Field Changes (last 30 days)

- `locations.dartmouth-hitchcock medical center|lebanon|new hampshire|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.banner md anderson cancer center|gilbert|arizona|united states` — added _(2026-05-12)_
- `locations.cedars-sinai medical center|los angeles|california|united states` — added _(2026-05-12)_
- `locations.university of miami|miami|florida|united states` — added _(2026-05-12)_
- `locations.orlando health cancer institute|orlando|florida|united states` — added _(2026-05-12)_
- `locations.moffitt cancer center|tampa|florida|united states` — added _(2026-05-12)_
- `locations.university of iowa hospitals and clinics|iowa city|iowa|united states` — added _(2026-05-12)_
- `locations.university of kansas medical center|kansas city|kansas|united states` — added _(2026-05-12)_
- `locations.henry ford hospital|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.mayo clinic rochester|rochester|minnesota|united states` — added _(2026-05-12)_
- `locations.hackensack meridian health|hackensack|new jersey|united states` — added _(2026-05-12)_
- `locations.northwell health|lake success|new york|united states` — added _(2026-05-12)_
- `locations.icahn school of medicine at mount sinai|new york|new york|united states` — added _(2026-05-12)_
- `locations.duke university medical center|durham|north carolina|united states` — added _(2026-05-12)_
- `locations.university hospitals of cleveland|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.radiation oncology and gamma knife center of oregon|portland|oregon|united states` — added _(2026-05-12)_
- `locations.pennsylvania state university|university park|pennsylvania|united states` — added _(2026-05-12)_
- `locations.ut southwestern medical|dallas|texas|united states` — added _(2026-05-12)_
- `locations.md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_
- `locations.university of washington medical center (uwmc) - radiation oncology center|seattle|washington|united states` — added _(2026-05-12)_
- `locations.cancer care northwest|spokane valley|washington|united states` — added _(2026-05-12)_
- `locations.london regional cancer center|london|ontario|canada` — added _(2026-05-12)_
- `locations.jewish general hospital|montreal|quebec|canada` — added _(2026-05-12)_
- `locations.atlantic clinical cancer research unit/qeii health sciences centre|halifax, nova scotia||canada` — added _(2026-05-12)_
- `locations.institut bergonié|bordeaux||france` — added _(2026-05-12)_
- `locations.chru de brest hôpital morvan|brest||france` — added _(2026-05-12)_
- `locations.centre georges françois leclerc|dijon||france` — added _(2026-05-12)_
- `locations.institut régional du cancer de montpellier|montpellier||france` — added _(2026-05-12)_
- `locations.tenon hospital|paris||france` — added _(2026-05-12)_
- `locations.chu de bordeaux, hôpital haut-lévêque|pessac||france` — added _(2026-05-12)_
- `locations.aberdeen royal infirmary|aberdeen|aberdeenshire|united kingdom` — added _(2026-05-12)_
- `locations.genesiscare|oxford|oxfordshire|united kingdom` — added _(2026-05-12)_
- `locations.addenbrookes hospital|cambridge||united kingdom` — added _(2026-05-12)_
- `locations.beatson west of scotland cancer centre|glasgow||united kingdom` — added _(2026-05-12)_
- `locations.imperial college london, saint mary's hospital|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04698915.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04698915*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*