[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597524":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":58,"centralContacts":63,"locations":72,"responsibleParty":91,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":11,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":11,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":11,"overallStatus":117,"whyStopped":11,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RP2 and FLOT","EXPERIMENTAL",null,[13,14,15,16,17,18,19,20],"Biological: RP2","Combination Product: 5-Fluorouracil","Combination Product: Leucovorin","Combination Product: Oxaliplatin","Combination Product: Docetaxel","Drug: Pegfilgrastim","Drug: Filgrastim","Procedure: Surgical Resection of Primary Tumor",[22,27,32,36,40,44,49,53],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"BIOLOGICAL","RP2","Upper endoscopy with RP2 intra-tumoral injection of 1 x 10(6) plaque forming units (PFU)\u002FmL for first intra-tumoral injection, up to 10mL of 1x107 PFU\u002FmL of RP2 for subsequent intra-tumoral injections. Injection will occur within 4 days prior of each cycle FLOT.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"COMBINATION_PRODUCT","5-Fluorouracil","5-Fluorouracil as part of the FLOT regimen 2,600mg\u002Fm2 intravenous infusion over 24 hours on day 1 of each 14-day cycle for 4 cycles.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Leucovorin","Leucovorin as part of the FLOT regimen 200mg\u002Fm2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.",[9],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Oxaliplatin","Oxaliplatin as part of the FLOT regimen 85mg\u002Fm2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.",[9],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Docetaxel","Docetaxel as part of the FLOT regimen 50mg\u002Fm2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.",[9],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"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.",[9],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"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.",[9],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"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.",[9],[59],{"name":60,"affiliation":61,"role":62},"William Chapin, MD, MSCE","Abramson Cancer Center at the University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":11,"email":68},"Jennifer Eads, MD","CONTACT","215-662-3141","Jennifer.Eads@pennmedicine.upenn.edu",{"name":60,"role":66,"phone":70,"phoneExt":11,"email":71},"215-662-7606","William.Chapin@pennmedicine.upenn.edu",[73],{"facility":61,"status":11,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Philadelphia","Pennsylvania","19104","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-75.16362,39.95238,{"lat":83,"lon":82},[86,90],{"name":87,"role":66,"phone":88,"phoneExt":11,"email":89},"Jennifer Walsh","609-668-0689","Jennifer.Walsh4@pennmedicine.upenn.edu",{"name":60,"role":62,"phone":11,"phoneExt":11,"email":11},{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[94],{"name":95,"class":96},"Replimune, Inc.","INDUSTRY","100597524","phase-2-neoadjuvant-intra-tumoral-rp2-and-flot-in-gastroesophageal-adenocarcinoma-100597524",false,"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","Inclusion Criteria:\n\n* Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n* 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.\n* 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:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmicroliter\n  * Platelets ≥100,000\u002Fmicroliter\n  * Total bilirubin ≤ the institutional upper limit of normal (ULN).\n  * AST and ALT ≤ 2.5 times the institutional ULN\n  * Serum creatinine ≤ 1.5 times the institutional ULN\n  * Hemoglobin ≥ 9 g\u002FdL\n\nExclusion Criteria\n\n* 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.\n* Per the investigator, has contraindications to receiving chemotherapy with FLOT.\n* 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.\n* 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.\n* 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.\n* 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\u002Fzoster (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.\n* Has a condition requiring systemic treatment with corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of first study treatment administration.\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10mg\u002Fday of prednisone equivalents are permitted.\n* Prior organ transplantation including allogeneic stem-cell transplantation.\n* Has a previous or concurrent malignancy. Exceptions include:\n\n  * Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\n  * Prior malignancy has been completely excised or removed and patient has been continuously disease free for \\> 5-years\n* 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.\n\n  * 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.\n* 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.\n\n  * 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.\n* Has a psychiatric illness, substance use, or other social conditions that, in the judgment of the investigator, would limit compliance with study requirements.","ALL","18 Years",{"count":107,"type":108},34,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","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.",[114,115,116],"Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-06-03",{"date":120,"type":121},"2026-06-05","ACTUAL",{"date":123,"type":108},"2026-09-01",{"date":125,"type":108},"2029-11-01",{"name":5,"class":6},1]