Cancer-Killing virus injected into tumors before surgery: a new hope?
NCT ID NCT07059611
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting a virus called RP2 directly into stomach and esophageal tumors, combined with standard FLOT chemotherapy, is safe and works better than chemotherapy alone before surgery. About 34 people with stage II or higher non-metastatic gastroesophageal cancer will receive the injections before each chemo cycle, then undergo surgery. The main goal is to see if the cancer is completely gone at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RP2 (a virus injected into tumors) and FLOT chemotherapy (5-fluorouracil, leucovorin, oxaliplatin, docetaxel)
- What this could lead to
- If it works, this could lead to a more effective pre-surgery treatment that kills more cancer cells and improves outcomes for people with gastroesophageal cancer.
- What could go wrong
- This is an early Phase 2 trial with only 34 people, so results may not apply widely. The combination could cause more side effects than chemo alone, and the virus injection may not be safe or effective for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a new drug boost immunotherapy against Hard-to-Treat stomach cancer?