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RP2 and FLOT for Gastroesophageal Adenocarcinoma

This study is looking at whether adding a treatment called RP2 directly into tumors of the stomach or esophagus, along with standard chemotherapy (FLOT), is safe and more effective before surgery. RP2 is a biological treatment injected into the tumor, and FLOT is a combination of chemotherapy drugs: 5-Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel. You may be able to join if you have certain types of esophageal, gastroesophageal junction, or gastric adenocarcinoma that has not spread, and you are generally in good health. The main goal is to see if this combination leads to a complete disappearance of cancer cells (pathologic complete response) after treatment and before surgery. The study plans to enroll 34 participants, but its current status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It is a Phase II study, and it plans to enroll 34 participants.
What's involved
You would receive RP2 injections directly into your tumor via upper endoscopy before each cycle of FLOT chemotherapy. This treatment would occur over approximately 4-5 months before surgical resection.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is assessed after completing treatment and surgery, typically 4-5 months from enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07059611

Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~34 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:RP25-FluorouracilLeucovorinOxaliplatinDocetaxelPegfilgrastim

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic complete response
Measured over 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.

Conditions

Gastric Adenocarcinoma
Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT07059611

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abramson Cancer Center at the University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • William Chapin, MD, MSCE · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center at the University of Pennsylvania

Who to contact

Jennifer Eads, MD
[email protected]
215-662-3141
Email the study team

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Eligibility criteria

Inclusion

Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform the appropriate surgical procedure based on patient's primary tumor site.
Patients must have normal organ and bone marrow function, as defined below, less than or equal to 14 days prior to the initiation of study therapy:
Absolute neutrophil count (ANC) ≥ 1,500/microliter
Platelets ≥100,000/microliter
Total bilirubin ≤ the institutional upper limit of normal (ULN).
AST and ALT ≤ 2.5 times the institutional ULN
Serum creatinine ≤ 1.5 times the institutional ULN
Hemoglobin ≥ 9 g/dL

Exclusion

Has received prior chemotherapy, radiation therapy, or immunotherapy (anti-programmed cell death protein-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) for the current malignancy.
Per the investigator, has contraindications to receiving chemotherapy with FLOT.
Per the sub-investigator (gastroenterologist) responsible for intra-tumoral injections or the investigator, patient has contraindications to repeated upper endoscopy for intra-tumoral injections. These could include medical conditions that would, per the judgment of the sub-investigator or investigator, inappropriately increase the risk of upper endoscopy.
Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on warfarin with a target international normalized ratio (INR) ≥ 2.5 that cannot be temporarily reversed to INR ≤ 1.7.
Active significant herpetic infections or prior complications of Herpes simplex virus-1 (HSV-1) infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \[IV\]) antivirals with known antiherpetic activity (e.g., acyclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of study treatment.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Available COVID-19 vaccines do not contain live virus and are allowed.
Has a condition requiring systemic treatment with corticosteroids (\>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of first study treatment administration.
Inhaled or topical steroids and adrenal replacement doses ≤ 10mg/day of prednisone equivalents are permitted.
Prior organ transplantation including allogeneic stem-cell transplantation.
Has a previous or concurrent malignancy. Exceptions include:
Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR
Prior malignancy has been completely excised or removed and patient has been continuously disease free for \> 5-years
Has a positive test result for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection with hepatitis B or hepatitis C. Testing will be performed as part of screening on the study.
Patients with a known history of hepatitis B or hepatitis C that have been effectively treated (with negative HBsAg and HCV RNA) will be eligible for enrollment on this criterion.
Has a known history of human immunodeficiency virus (HIV) with detectable viral load. HIV testing will not be performed as part of screening for the study.
Patients with known HIV infection with an undetectable viral load and who are on a stable highly active antiviral regimen per the investigator's assessment will eligible to enroll.
Has a psychiatric illness, substance use, or other social conditions that, in the judgment of the investigator, would limit compliance with study requirements.

What this trial measures

  • Pathologic complete responseAssessed 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.

    Pathologic complete response defined as the absence of residual invasive cancer on histologic examination of the resected esophageal, GEJ, or gastric adenocarcinoma specimen and all sampled regional lymph nodes. This will be assessed in the efficacy population who received at least three intra-tumoral injections of RP2 and underwent subsequent surgical resection.