Misted chemotherapy shows promise for advanced stomach cancer in early trial
NCT ID NCT06675136
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new method of delivering chemotherapy directly into the abdomen as a fine mist under pressure (PIPAC) for people with stomach cancer that has spread to the lining of the belly. The study combines this misted chemotherapy (nab-paclitaxel) with standard second-line drugs given through a vein. The main goals are to find the safest dose and see if the combination is tolerable. About 30 participants who have already tried one line of treatment will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nab-paclitaxel (a form of chemotherapy) given as a pressurized mist into the abdomen, plus paclitaxel and ramucirumab (another chemotherapy and an antibody) given through a vein
- What this could lead to
- If this works, it could offer a new treatment option for stomach cancer that has spread to the lining of the belly, potentially slowing the disease.
- What could go wrong
- This is a very early (Phase 1) trial with only 30 people, so the main goal is safety, not effectiveness. The combination may cause serious side effects or not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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