What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biopsy, Biospecimen Collection, or Computed Tomography. The registry lists allocation as na. This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases).
They plan to enroll about 30 people at Duarte. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases
Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Medical Device Usage and Evaluation, Nab-paclitaxel, Paclitaxel, Questionnaire Administration, Ramucirumab
Primary outcome (registry wording): Dose-limiting toxicity (DLT)