Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases
NCT ID: NCT06675136
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-10-29
2029-01-14
Brief Summary
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Detailed Description
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I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of nab-paclitaxel PIPAC when given in combination with standard-of-care second-line systemic therapy (paclitaxel, ramucirumab).
II. To assess the safety and tolerability of nab-paclitaxel PIPAC plus systemic paclitaxel and ramucirumab, and accompanying dose modification plan, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.
SECONDARY OBJECTIVES:
I. To evaluate the anti-tumor activity of nab-paclitaxel when given in combination with standard-of-care second-line systemic therapy (paclitaxel, ramucirumab), as assessed by:
Ia. Response Evaluation Criteria in Solid Tumors (RECIST), if available, version 1.1 via computed tomography (CT) scan at baseline and every 8 weeks until disease progression; Ib. Peritoneal Regression Grading Score (PRGS) via biopsy at each PIPAC cycle (both pre-PIPAC and post-PIPAC peritoneal samples will be obtained); Ic. Peritoneal Carcinomatosis Index (PCI) at the time of laparoscopy; and Id. Overall survival (OS) and progression-free survival (PFS) estimates at 6-months, 1-year and 2-years.
II. To estimate the PIPAC technical failure rate. III. To characterize and evaluate peritoneal tumor associated complications. IV. To characterize and evaluate post-operative surgical complications by Clavien-Dindo classification evaluated at 30 days after each PIPAC technical failure rate.
V. To evaluate patient-reported health state/quality of life and symptoms before treatment and at 6, 12, 18, and 24 weeks/off study, as measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) and MD Anderson Symptom Inventory (MDASI).
EXPLORATORY OBJECTIVES:
I. Characterize the peritoneal tumor and immune tumor microenvironment changes in response to therapy.
II. Evaluate the pharmacokinetics of nab-paclitaxel PIPAC. III. Evaluate patients' quality of life during nab-paclitaxel PIPAC plus systemic therapy.
OUTLINE: This is a dose-escalation study of nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab followed by a dose-expansion study.
Patients receive nab-paclitaxel PIPAC intraperitoneally (IP) over 40 minutes on day 1 and standard of care (SOC) paclitaxel intravenously (IV) over 60 minutes on days 15, 22, 29, 43, and 50 and ramucirumab IV over 30-60 minutes on days 15, 29 and 43 of each cycle. Cycles repeat every 8 weeks (56 days) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may then continue SOC paclitaxel IV on days 1, 8, and 15 and ramucirumab IV on days 1 and 15 of each cycle per physician as deemed appropriate. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, tumor biopsy, and CT or magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at 4 weeks, then every 3 months for year 1 followed by every 6 months until progression or initiation of a new systemic anti-cancer therapy or death, whichever occurs first.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)
Patients receive nab-paclitaxel PIPAC IP over 40 minutes on day 1 and SOC paclitaxel IV over 60 minutes on days 15, 22, 29, 43, and 50 and ramucirumab IV over 30-60 minutes on days 15, 29 and 43 of each cycle. Cycles repeat every 8 weeks (56 days) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may then continue SOC paclitaxel IV on days 1, 8, and 15 and ramucirumab IV on days 1 and 15 of each cycle per physician as deemed appropriate. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, tumor biopsy, and CT or MRI throughout the study.
Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Medical Device Usage and Evaluation
Given PIPAC
Nab-paclitaxel
Given IP
Paclitaxel
Given IV
Questionnaire Administration
Ancillary studies
Ramucirumab
Given IV
Interventions
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Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Medical Device Usage and Evaluation
Given PIPAC
Nab-paclitaxel
Given IP
Paclitaxel
Given IV
Questionnaire Administration
Ancillary studies
Ramucirumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Yanghee Woo
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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Yanghee Woo
Role: primary
Other Identifiers
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NCI-2024-08883
Identifier Type: REGISTRY
Identifier Source: secondary_id
24445
Identifier Type: OTHER
Identifier Source: secondary_id
24445
Identifier Type: -
Identifier Source: org_study_id