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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06675136
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Medical Device Usage and Evaluation — OTHER
    Given PIPAC
  • Nab-paclitaxel — DRUG
    Given IP
  • Paclitaxel — DRUG
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Ramucirumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
Nov 2025
Primary completion
Jan 14, 2029
Completion
Jan 14, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: Up to 6 weeks after the first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Yanghee Woo
[email protected]
626-218-0220
Yanghee Woo (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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