NCT07059611

Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma

Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-arm, phase II study using a Simon two-stage optimal design with a 6 patient safety run-in evaluating the addition of intra-tumoral injections of RP2 to standard of care perioperative FLOT for patients with stage II or higher, non-metastatic esophageal, gastroesophageal junction (GEJ), or gastric adenocarcinoma. We hypothesize that the addition of RP2 to perioperative FLOT will be safe and will significantly improve pathologic complete response (pCR) rate compared to the historical weighted average of 12% observed with perioperative FLOT in the ESOPEC trial, MATTERHORN trial, and FLOT4 trial.

Conditions

• Gastric Adenocarcinoma
• Esophageal Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	RP2	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.
COMBINATION_PRODUCT	5-Fluorouracil	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.
COMBINATION_PRODUCT	Leucovorin	Leucovorin as part of the FLOT regimen 200mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
COMBINATION_PRODUCT	Oxaliplatin	Oxaliplatin as part of the FLOT regimen 85mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
COMBINATION_PRODUCT	Docetaxel	Docetaxel as part of the FLOT regimen 50mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
DRUG	Pegfilgrastim	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.
DRUG	Filgrastim	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.
PROCEDURE	Surgical Resection of Primary Tumor	Following 4 cycles of preoperative FLOT with RP2 injections, surgical resection of esophageal, GEJ, or gastric primary tumor per standard of care practice.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-01
• Completion: 2029-11-01
• First posted: 2025-07-11
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study