Clinical Stage IVB Gastric Cancer AJCC v8Phase 1NCT06675136
Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases
A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Clinical Stage IVB Gastric Cancer AJCC v8 and Metastatic Gastric Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Gastric Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum
- What is being tested?
- Biopsy, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to 14 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Yanghee Woo, 626-218-0220, yhwoo@coh.org
Yanghee Woo
About this study
Official title: 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 the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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
- Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Gastric Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum
- Being tested
- Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Medical Device Usage and Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Medical Device Usage and EvaluationOther
Given PIPAC
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, ABI007, Abraxane
Given IP
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
Questionnaire AdministrationOther
Ancillary studies
RamucirumabBiological
Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC 1121B, IMC-1121B
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) | Experimental | 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. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Medical Device Usage and Evaluation; Drug: Nab-paclitaxel; Drug: Paclitaxel; Other: Questionnaire Administration; Biological: Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
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.
Measured: Up to 6 weeks after the first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) treatment
Secondary outcomes (12)
Incidence of treatment-related adverse events (AEs)
Will be evaluated and graded based on NCI CTCAE v 5.0. The number and percent of patients with AEs will be tabulated by system organ class and preferred term using the Medical Dictionary for Regulatory Activities preferred term dictionary. The tabulations will be generated so that the number and percent of patients with events in each severity, relatedness, and serious category can be obtained for each preferred term. Listings and narratives will be provided for deaths on study, serious AEs, DLTs, and events leading to discontinuation of treatment.
Measured: Up to 4 weeks after last dose of nab-paclitaxel
Incidence of post-operative surgical complications
Will be evaluated using Clavien-Dindo classification. Results will be strictly descriptive in nature.
Measured: At 4 weeks post-PIPAC procedure
Objective response rate (ORR)
Will be evaluated according to Response Evaluation Criteria in Solid Tumors v 1.1. ORR will be defined as the percentage of evaluable patients who have achieved complete response (CR), partial response (PR), or stable disease (SD). Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.
Measured: Up to 2 years
Peritoneal Carcinomatosis Index (PCI)
PCI will be defined as the percentage of evaluable patients who have achieved CR, PR, or SD. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson
Measured: At time of laparoscopy
Peritoneal Regression Grading Score (PRGS)
PRGS will be defined as the percentage of evaluable patients who have achieved a decrease in the PRGS over successive biopsies. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson
Measured: At baseline and post-PIPAC, assessed up to 2 years
Progression-free survival (PFS)
PFS will be estimated using the Kaplan-Meier estimator and 95% confidence intervals will be calculated using the logit transformation and the Greenwood variance estimate.
Measured: From first PIPAC to progression of disease, assessed up to 2 years
Overall survival (OS)
OS will be estimated using the Kaplan-Meier estimator and 95% confidence intervals will be calculated using the logit transformation and the Greenwood variance estimate.
Measured: From initiation of treatment to death or last contact, whichever occurs first up to 2 years
PIPAC technical failure rate
The technical failure rate will be calculated. The device malfunction rate will also be calculated. Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.
Measured: Up to 2 years
Patient-reported health status and quality of life
Will be measured using the European Quality of Life Five Dimension Five Level Scale and will be summarized with descriptive statistics.
Measured: At baseline and at 6, 12, 18 and 24 weeks off study
Patient-reported symptoms
Will be measured using the MD Anderson Symptom Inventory and will be summarized with descriptive statistics.
Measured: At baseline and at 6, 12, 18 and 24 weeks off study
Time to peritoneal tumor associated complications
Will be estimated using the Kaplan-Meier estimator and 95% confidence intervals will be calculated using the logit transformation and the Greenwood variance estimate.
Measured: Up to 2 years
Functional status
Will be measured by the number of daily steps before and after treatments.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start29 Oct 2025
- Primary completion14 Jan 2029 (estimated)
- Study completion14 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage IVB Gastric Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yanghee Woo, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675136
- Sponsor's protocol ID
- 24445
- Other IDs
- NCI-2024-08883, 24445, P30CA033572
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT06675136
- Acronym / sponsor ID
- 24445
- Conditions
- Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Gastric Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 14 Jan 2029 (estimated)
- Study completion
- 14 Jan 2029 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) | Experimental | Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Other: Medical Device Usage and Evaluation, Drug: Nab-paclitaxel, Drug: Paclitaxel, Other: Questionnaire Administration, Biological: RamucirumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin [FOLFOX] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)
- Documented informed consent of the participant and/or legally authorized representative
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo tumor biopsy | Procedure or surgery | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| Medical Device Usage and EvaluationGiven PIPAC | Other | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| Nab-paclitaxelAlso: ABI 007, ABI-007, ABI007, AbraxaneGiven IP | Drug | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
| RamucirumabAlso: Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC 1121B, IMC-1121BGiven IV | Biological | Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 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.
12 secondary outcomes
Incidence of treatment-related adverse events (AEs)
Time frame: Up to 4 weeks after last dose of nab-paclitaxel
Incidence of post-operative surgical complications
Time frame: At 4 weeks post-PIPAC procedure
Objective response rate (ORR)
Time frame: Up to 2 years
Peritoneal Carcinomatosis Index (PCI)
Time frame: At time of laparoscopy
Peritoneal Regression Grading Score (PRGS)
Time frame: At baseline and post-PIPAC, assessed up to 2 years
Progression-free survival (PFS)
Time frame: From first PIPAC to progression of disease, assessed up to 2 years
Overall survival (OS)
Time frame: From initiation of treatment to death or last contact, whichever occurs first up to 2 years
PIPAC technical failure rate
Time frame: Up to 2 years
Patient-reported health status and quality of life
Time frame: At baseline and at 6, 12, 18 and 24 weeks off study
Patient-reported symptoms
Time frame: At baseline and at 6, 12, 18 and 24 weeks off study
Time to peritoneal tumor associated complications
Time frame: Up to 2 years
Functional status
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanghee Woo principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Clinical Stage IVB Gastric Cancer AJCC v8 and Metastatic Gastric Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 6 weeks after the first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.