Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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.
Absolute neutrophil count (ANC) ≥ 1,500/microliter
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RP2
- 5-Fluorouracil
- Leucovorin
- Oxaliplatin
- Docetaxel
- Pegfilgrastim
- Filgrastim
- Surgical Resection of Primary Tumor
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Abramson Cancer Center at Penn Medicine
Lead sponsor
Replimune, Inc.
Collaborator
Source ClinicalTrials.gov