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Gastric AdenocarcinomaCancerGut healthBiologicalCombination productDrugProcedurePhase 2

What this study is

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.

What's being tested

  • RP2

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

Official title
Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma
Sponsor
Abramson Cancer Center at Penn Medicine
Conditions
Gastric Adenocarcinoma · Esophageal Adenocarcinoma · Gastroesophageal Junction Adenocarcinoma
Enrolling
34 people
Starts
2027-04-01
Est. completion
2029-11-01
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗