RecruitingPhase 1NCT06675136

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

Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases


Sponsor

City of Hope Medical Center

Enrollment

30 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for stomach cancer that has spread to the lining of the abdomen (called peritoneal metastases). It combines a drug delivered directly into the abdominal cavity using pressurized aerosol (PIPAC) with intravenous chemotherapy and a drug called ramucirumab that cuts off blood supply to tumors. **You may be eligible if...** - You are 18 or older with confirmed stomach cancer that has spread to the peritoneum (lining of the abdomen) - Your cancer has progressed after first-line chemotherapy - You have had no more than 4 cycles of second-line treatment without progression - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - Your cancer has spread beyond the abdomen to other distant organs in a way that makes this approach inappropriate - Your organ function (heart, kidneys, liver, blood) does not meet the required thresholds - You have had a bowel obstruction or other abdominal complications that prevent safe surgery access Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERMedical Device Usage and Evaluation

Given PIPAC

DRUGNab-paclitaxel

Given IP

DRUGPaclitaxel

Given IV

OTHERQuestionnaire Administration

Ancillary studies

BIOLOGICALRamucirumab

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06675136


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