Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07059611
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RP2 — BIOLOGICAL
    Upper endoscopy with RP2 intra-tumoral injection of 1 x 10(6) plaque forming units (PFU)/mL for first intra-tumoral injection, up to 10mL of 1x107 PFU/mL of RP2 for subsequent intra-tumoral injections. Injection will occur within 4 days prior of each cycle FLOT.
  • 5-Fluorouracil — COMBINATION_PRODUCT
    5-Fluorouracil as part of the FLOT regimen 2,600mg/m2 intravenous infusion over 24 hours on day 1 of each 14-day cycle for 4 cycles.
  • Leucovorin — COMBINATION_PRODUCT
    Leucovorin as part of the FLOT regimen 200mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
  • Oxaliplatin — COMBINATION_PRODUCT
    Oxaliplatin as part of the FLOT regimen 85mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
  • Docetaxel — COMBINATION_PRODUCT
    Docetaxel as part of the FLOT regimen 50mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
  • Pegfilgrastim — DRUG
    Pegfilgrastim or Filgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles.
  • Filgrastim — DRUG
    Filgrastim or Pegfilgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles.
  • Surgical Resection of Primary Tumor — PROCEDURE
    Following 4 cycles of preoperative FLOT with RP2 injections, surgical resection of esophageal, GEJ, or gastric primary tumor per standard of care practice.

Study Details

The research study is being conducted to study whether performing injections of a new treatment, called RP2, directly into stomach and esophagus tumors along with standard chemotherapy (called FLOT) is safe and whether it does a better job of killing cancer before surgery compared to chemotherapy alone.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RP2 and FLOT

Primary Outcome Measure

Pathologic complete response [ Time Frame: Assessed after completion of neoadjuvant FLOT and intra-tumoral injections of RP2 and surgical resection. This will typically be in the range of 4-5 months from the time of enrollment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at the University of PennsylvaniaPhiladelphiaPennsylvania19104
Jennifer Walsh
[email protected]
609-668-0689
William Chapin, MD, MSCE (PRINCIPAL_INVESTIGATOR)

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By research site
Abramson Cancer Center at the University of Pennsylvania· Philadelphia, PA

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