Actively Recruiting
Phase 1 Trial of Nab-Paclitaxel PIPAC Combined With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases
Led by City of Hope Medical Center · Updated on 2025-11-10
30
Participants Needed
1
Research Sites
N/A
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
Researchers are studying a new way to treat stomach cancer that has spread to the lining of the abdomen, called peritoneal metastases. This phase 1 trial is testing the safety, side effects, and best dose of a chemotherapy drug called nab-paclitaxel delivered as a pressurized aerosol directly into the abdomen (PIPAC). The study also evaluates how well this treatment works when combined with standard second-line chemotherapy drugs paclitaxel and ramucirumab. Nab-paclitaxel is a special form of paclitaxel that may have fewer side effects and better delivery to tumors. Ramucirumab is an antibody that may stop tumors from growing new blood vessels. Participants receive nab-paclitaxel through PIPAC into the abdomen on day 1 of each cycle. They also receive paclitaxel and ramucirumab intravenously on specific days within an 8-week cycle, which may be repeated up to three times if the disease does not progress or side effects are tolerable. After this, patients may continue with paclitaxel and ramucirumab on a 28-day cycle as decided by their doctor. Throughout the study, patients undergo blood tests, tumor biopsies, and imaging scans such as CT or MRI. During the trial, researchers closely monitor participants for side effects and dose limits, tumor response using imaging and biopsy scores, progression of cancer, and overall survival. They also assess patient quality of life and symptoms at different time points. After treatment ends, patients are followed for up to two years with regular visits to track their health and any new treatments. The study aims to find the best dose and gather information about safety, effectiveness, and how the tumor environment changes with therapy.
CONDITIONS
Brief 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 including fluorouracil-based chemotherapy with or without immunotherapy
- Prior immunotherapy is allowed
- Up to 4 cycles of second-line therapy allowed if no progression is documented
- Documented informed consent from participant or legal representative
- Age 18 years or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed gastric adenocarcinoma
- Visible peritoneal metastatic disease on imaging or laparoscopy
- Fully recovered from acute toxic effects of prior anti-cancer therapy except minor issues
- Urinary protein ≤ 1+ on dipstick or routine analysis; if ≥ 2+, 24-hour urine protein < 1000mg
- Complete medical history and physical exam within 28 days prior to treatment
- Adequate blood counts and organ function within 28 days prior to treatment
- Seronegative or stable HIV with adequate CD4 count and undetectable viral load
- Documented hepatitis B and C status with controlled viral load if positive
- Women of childbearing potential must have negative pregnancy test
- Agreement to use effective contraception or abstain from heterosexual activity during study and for 14 months after last treatment
You will not qualify if you...
- Intolerance to taxane chemotherapy drugs
- Bowel obstruction requiring total parenteral nutrition
- History or current brain or subdural metastases
- Life expectancy less than 3 months
- Treatment with therapeutic antibiotics within 14 days before treatment cycle 1
- Prior malignancy except certain treated cancers or those disease-free for 2 years
- Allergic reactions to taxanes or similar compounds
- Uncontrolled illnesses such as uncontrolled hypertension
- History of arterial thromboembolic events like heart attack or stroke
- History of gastrointestinal perforation
- Pregnant or breastfeeding women
- Any condition that contraindicates participation due to safety concerns
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 weeks or until disease progression or unacceptable toxicity
Participants receive nab-paclitaxel PIPAC intraperitoneally on day 1 and standard-of-care paclitaxel and ramucirumab intravenously on specified days in 8-week cycles up to 3 cycles, followed by optional continuation of paclitaxel and ramucirumab in 28-day cycles as deemed appropriate by their physician.
Multiple visits including day 1, days 15, 22, 29, 43, and 50 of each 8-week cycle, then visits every 28 days for continued treatment
Duration - Up to 2 years or until disease progression, new therapy initiation, or death
After treatment completion, participants are followed up to monitor safety, tumor progression, and quality of life.
1 visit at 4 weeks post-treatment, then visits every 3 months for the first year, then every 6 months thereafter
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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