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Nab-Paclitaxel PIPAC for Stomach Cancer with Peritoneal Metastases

This study is testing a new way to treat stomach cancer that has spread to the lining of the abdomen (peritoneal metastases). It combines a treatment called nab-paclitaxel PIPAC (pressurized intraperitoneal aerosolized chemotherapy) with standard chemotherapy drugs, paclitaxel and ramucirumab. Nab-paclitaxel is a form of paclitaxel that may have fewer side effects and work better. The study aims to find the safest and most effective dose of nab-paclitaxel PIPAC when given with these other drugs. Researchers will also look at how well this combination shrinks tumors and improves survival. You may be eligible if you have stomach cancer with peritoneal metastases and your first-line chemotherapy treatment was not successful. The study plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 30 participants to determine the best dose and safety of the treatment.
What's involved
You would undergo a tumor biopsy, blood sample collection, CT scans, and MRI scans. You would also receive the PIPAC treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure dose-limiting toxicity up to 6 weeks after the first PIPAC treatment. Tumor activity will be assessed every 8 weeks until disease progression, and overall and progression-free survival will be estimated at 6 months, 1 year, and 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06675136

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~30 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingMedical Device Usage and EvaluationNab-paclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT)
Measured over Up to 6 weeks after the first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) treatment

Conditions

Clinical Stage IVB Gastric Cancer AJCC v8
Metastatic Gastric Adenocarcinoma
Metastatic Malignant Neoplasm in the Peritoneum

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Gastric Adenocarcinoma

NCT06675136

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yanghee Woo · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Yanghee Woo
[email protected]
626-218-0220
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Dose-limiting toxicity (DLT)Up to 6 weeks after the first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) treatment

    Will be evaluated and graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Toxicities will be summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome. Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.