Nab‑paclitaxel PIPAC with paclitaxel and ramucirumab for stomach cancer that has spread to the peritoneum
Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases
This phase I trial tests whether giving nab‑paclitaxel as a pressurized intraperitoneal aerosol (PIPAC) together with systemic paclitaxel and ramucirumab is safe and can help adults whose stomach cancer has spread to the peritoneal lining after first‑line therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | immunotherapy, ramucirumab, chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT06675136 on ClinicalTrials.gov |
What this trial studies
This Phase 1, dose‑finding trial combines intraperitoneal aerosolized nab‑paclitaxel (PIPAC) with standard second‑line systemic paclitaxel and ramucirumab to determine the maximum tolerated dose and recommended Phase 2 dose. Patients undergo laparoscopic PIPAC procedures with biopsies and serial imaging, and are followed for treatment‑related toxicities, surgical complications, and technical success of PIPAC. Secondary measures include tumor response by CT/RECIST when measurable, peritoneal regression grading from biopsies, peritoneal carcinomatosis index at laparoscopy, and survival outcomes. The study enrolls adults with gastric adenocarcinoma and visible peritoneal metastases who have progressed after first‑line platinum/fluoropyrimidine therapy.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed gastric adenocarcinoma and visible peritoneal metastases who have failed first‑line platinum/fluoropyrimidine therapy, have ECOG performance status 0–1, and can tolerate laparoscopic procedures are the intended candidates.
Not a fit: Patients with poor performance status (ECOG ≥2), non‑adenocarcinoma stomach cancers, diffuse disease that prevents safe laparoscopy, or who have not yet received prior first‑line therapy are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could deliver higher chemotherapy concentrations directly to peritoneal tumors with acceptable toxicity, potentially improving local tumor control and outcomes for patients with peritoneal spread.
How similar studies have performed: Prior small PIPAC studies have shown promising local drug delivery and some peritoneal tumor responses, but combining nab‑paclitaxel PIPAC with systemic paclitaxel and ramucirumab is a novel regimen with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count ≥ 200/µL, and have an undetectable viral load * 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) Exclusion Criteria: * Intolerance to taxanes * Bowel obstruction requiring exclusive total parenteral nutrition * Any history of, or current, brain or subdural metastases * Life expectancy \< 3 months * Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved * Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (taxanes, etc.) * Clinically significant uncontrolled illness such as uncontrolled hypertension (HTN) * History of arterial thromboembolic events such as myocardial infarction (MI), cerebrovascular accident (CVA) * History of gastrointestinal (GI) perforation * FEMALES ONLY: Pregnant or breastfeeding * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Yanghee Woo — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.