Actively Recruiting
Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases
Led by City of Hope Medical Center · Updated on 2025-11-10
30
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
CONDITIONS
Official Title
Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have failed first-line systemic therapy with fluorouracil, leucovorin calcium, oxaliplatin (FOLFOX) with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy
- Prior immunotherapy is allowed
- Up to 4 cycles of second-line therapy allowed if no progression is documented
- Documented informed consent from participant or legally authorized representative
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or approval by study PI if unavailable
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed gastric adenocarcinoma
- Visible peritoneal metastatic disease on imaging or diagnostic laparoscopy
- Fully recovered from acute toxic effects of prior therapy (except alopecia, hearing loss, or minor lab abnormalities) at grade 1 or less
- Urinary protein level ≤ 1+ on routine test or < 1000 mg protein in 24-hour urine if higher
- Complete medical history and physical exam within 28 days before treatment
- Absolute neutrophil count ≥ 1,500/mcL within 28 days before treatment
- Platelets ≥ 100,000/mcL within 28 days before treatment
- Hemoglobin ≥ 8 g/dL within 28 days before treatment
- Serum albumin ≥ 2.8 g/dL within 28 days before treatment
- Total bilirubin ≤ 1.5 times upper normal limit (ULN) within 28 days before treatment
- AST and ALT ≤ 5 times ULN within 28 days before treatment
- INR, PT, PTT ≤ 1.5 times ULN within 28 days before treatment
- Creatinine clearance ≥ 45 mL/min within 28 days before treatment
- Seronegative for HIV or stable on therapy if positive
- Documented hepatitis B and C status with specified viral load limits and treatment
- Negative pregnancy test for women of childbearing potential within 28 days before treatment
- Agreement to use effective birth control or abstain during study and 14 months after
- Childbearing potential defined as not surgically sterilized or not free from menses >1 year
You will not qualify if you...
- Intolerance to taxane medications
- Bowel obstruction requiring total parenteral nutrition
- History or current brain or subdural metastases
- Life expectancy less than 3 months
- Treatment with therapeutic oral or IV antibiotics within 14 days before treatment start (prophylactic antibiotics allowed if infection resolved)
- Prior malignancies except certain treated cancers in remission or disease-free for 2 years
- Allergic reactions to study agent-related compounds (e.g., taxanes)
- Clinically significant uncontrolled illnesses such as uncontrolled hypertension
- History of arterial blood clots like heart attack or stroke
- History of gastrointestinal perforation
- Pregnant or breastfeeding women
- Any condition or concern by investigator that contraindicates participation due to safety
- Inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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