Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases

Inclusion Criteria

• •Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin \[FOLFOX\] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)
• •* Prior immunotherapy allowed
• •* Up to 4 cycles of second-line therapy allowed if no progression is documented
• •Documented informed consent of the participant and/or legally authorized representative
• •* Assent, when appropriate, will be obtained per institutional guidelines
• •Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• •* If unavailable, exceptions may be granted with study principal investigator (PI) approval
• •Age: ≥ 18 years
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Histologically or cytologically confirmed gastric adenocarcinoma
• •Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by RECIST 1.1)
• •Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) ≤ grade 1 of prior anti-cancer therapy
• •The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine must be collected and must demonstrate \< 1000mg protein in 24 hours
• •Complete medical history and physical exam (within 28 days prior to day 1 of protocol therapy)
• •Absolute neutrophil count (ANC) ≥ 1,500/mcL (within 28 days prior to day 1 of protocol therapy)
• •Platelets ≥ 100,000/mcL (within 28 days prior to day 1 of protocol therapy)
• •Hemoglobin ≥ 8 g/dL (within 28 days prior to day 1 of protocol therapy)
• •Serum albumin ≥ 2.8 g/dL (within 28 days prior to day 1 of protocol therapy)
• •Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \< 1.5 mg/dL) (within 28 days prior to day 1 of protocol therapy)
• •Aspartate aminotransferase (AST) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)
• •Alanine aminotransferase (ALT) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)
• •International normalized ratio (INR) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)
• •Prothrombin time (PT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)
• •Partial thromboplastin time (PTT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)
• •Calculated creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol therapy)
• •Seronegative for HIV antigen (Ag)/antibody (Ab) combo (within 28 days prior to day 1 of protocol therapy)
• •Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (within 28 days prior to day 1 of protocol therapy)
• •* For patients with active HBV, HBV deoxyribonucleic acid (DNA) \< 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)
• •* If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable
• •WOMEN OF CHILDBEARING POTENTIAL (WOCBP): Negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol therapy)
• •* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• •Agreement by females and males of childbearing potential to use an effective method of birth control (e.g., licensed hormonal/barrier methods or surgery intended to prevent pregnancy \[or with a side effect of pregnancy prevention\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy.
• •* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)